Wednesday, December 4, 2024

Teva Presents Data from SPACE Study

(12/4, The Fly) ...Teva presented data from its Phase 3 SPACE study evaluating the efficacy and safety of Ajovy for the prevention of episodic migraine in children and adolescent patients aged 6-17 years. The trial showed statistically significant superior efficacy compared to placebo over 12 weeks with a favorable safety profile consistent with that observed in the adult population... Full

Teva Pharmaceutical Says Migraine Prevention Drug Shows Efficacy in Younger Patients

(12/4, MT Newswires) ...Teva Pharmaceutical Industries said Wednesday a phase 3 study of its fremanezumab drug to prevent episodic migraine in patients aged 6 to 17 years showed "statistically significant superior efficacy" compared with placebo...Teva said it continues to study the impact of fremanezumab on pediatric patients with chronic migraines and its long-term safety... Full

Coherus Sells its Last Biosimilar Udenyca to Intas for Up to $558M as Company Homes in On Novel Cancer Meds

(12/3, Fraiser Kansteiner, Fierce Pharma) ...Coherus has agreed to sell its biosimilar Udenyca—which references Amgen's febrile neutropenia drug Neulasta—to Intas Pharmaceuticals for up to $558.4 million. The deal, which is expected to close by the end of 2025's first quarter, will see Coherus receive $483.4 million upfront, plus $75 million in potential sales milestones, the company said Tuesday... Full

Sandoz to Invest $80M to Boost Capacity at Turkey Plant

(12/4, Ercan Ersoy, Bloomberg) ...Capacity of plant at Gebze, near Istanbul, will be raised by 50% to 15b tablets a year, Sandoz's Turkish unit says in emailed statement. Gebze plant is among the biggest 3 Sandoz manufacturing facilities around the world; its $115m of exports to 60 countries in 2023 made up 10% of Turkey's total drug sales abroad... Sub. Req’d

Lupin Takes A Step Closer To $1Bn US Janumet Opportunity

(12/3, Dean Rudge, Generics Bulletin) ...Lupin has welcomed tentative generic approval for one of the most sought-after small molecule opportunities in the US – Merck & Co's Janumet (metformin/sitagliptin) to treat type 2 diabetes, which has attracted dozens of abbreviation new drug application sponsors. The Indian firm said that it would look to manufacture its generic metformin/sitagliptin 50mg/500mg and 50mg/1,000mg tablets at its Pithampur facility in India... Global Sub. Full

Outlook Holds Out Hope For Wet AMD Approval Despite Phase III Topline Miss

(12/3, Alaric DeArment, Generics Bulletin) ...Outlook said the NORSE EIGHT trial did not meet its primary endpoint of showing that ONS-5010 was noninferior to ranibizumab at eight weeks, but it will file for US FDA approval anyway. Despite the primary endpoint miss, the company remains hopeful about FDA approval, though one analyst said the results cloud its prospects. The drug nevertheless remains approved and in the process of launching in Europe. Also, Outlook has addressed FDA concerns that led to a complete response letter last year... Global Sub. Full

Alembic Pharma Gets USFDA Nod for Olopatadine Hydrochloride Eye Drops

(12/4, Business Standard) ...Alembic Pharmaceuticals announced that it has received tentative approval from the US Food & Drug Administration for its abbreviated new drug application, Olopatadine Hydrochloride Ophthalmic Solution USP. The approved ANDA is therapeutically equivalent to the reference listed drug product, Pataday Once Daily Relief Ophthalmic Solution, of Alcon Laboratories, Inc... Full

Biogen Expects Steady Growth for Alzheimer's Drug Leqembi in Near Term

(12/3, Mariam Sunny, Reuters) ...Biogen expects growth of its keenly watched Alzheimer's disease drug, Leqembi, to see a "linear trend" in the United States in the near term, a company executive said at a healthcare conference on Tuesday..."I would expect a linear trend...at this point, until some things sort of change in the market," Alisha Alaimo, Biogen's head of North America, said at the Evercore HealthCONx Conference... Full

Eli Lilly's Zepbound Defeats Novo Nordisk's Wegovy in Head-to-Head Weight Loss Trial

(12/4, Kevin Dunleavy, Fierce Pharma) ...Wednesday, the answer finally arrived as Lilly revealed results from a study that showed that its obesity drug Zepbound was 47% more effective than Novo's Wegovy in helping patients lose weight. In the SURMOUNT-5 study, while participants taking Zepbound lost an average of 20.2% of their weight after 72 weeks, those on Wegovy lost 13.7% of their weight. The results translated to an average weight loss of 50.3 pounds (22.8 kg) for patients on Zepbound and 33.1 pounds (15 kg) for those taking Wegovy... Full

Takeda Puts Up to $1.3B On The Line for Keros' Blood Cancer Anemia Drug

(12/3, Tristan Manalac, BioSpace) ...Keros' elritercept has shown promising efficacy signals in myelofibrosis and myelodysplastic syndromes and could pose a formidable challenge to Bristol Myers Squibb's Reblozyl. Takeda Pharmaceuticals on Tuesday inked an exclusive licensing deal with Massachusetts-based biotech Keros Therapeutics to advance a potential competitor to Bristol Myers Squibb's blockbuster injection Reblozyl (luspatercept)... Full

Granules India's Loss is Which Pharma Company's Gain?

(12/4, Hormaz Fatakia, CNBC TV-18) ...Granules India Ltd.'s shares fell 10% on Tuesday after the USFDA granted an Official Action Indicated (OAI) status to its crucial Gagillapur facility, which had earlier received a form 483 with six observations...Investec analysed Granules' on-market US product portfolio and saw companies that have product overlap with Granules...Investec believes that Aurobindo Pharma has the most products overlapping with granules, including acetaminophen, ER metformin, ibuprofen, fexofenadine, and guaifenesin ER... Full

Nearly 30% of US Drugstores Closed in One Decade, Study Shows

(12/3, Tom Murphy, Associated Press) ...Drugstores have been dealing with shrinking reimbursement for prescriptions, rising costs and changing customer shopping habits. The chains have been closing money-losing stores and transferring prescription files to more profitable locations... Full

Concerns Over PREVAIL Act Persist, Even With Amendment To Shield Off-Patent Drugs

(12/3, Urte Fultinaviciute, Generics Bulletin) ...Despite the US legislation gaining support from Democratic candidates, who have fought against anticompetitive pharma behavior, many have shared concerns that the amended PREVAIL Act will still negatively impact generic drugs... Sub. Req’d

Bloomberg, Gottlieb Intensify Push To Sink RFK Jr.'s HHS Nomination

(12/3, Maaisha Osman, InsideHealthPolicy) ...Businessman and former New York City Mayor Mike Bloomberg slammed Robert F. Kennedy Jr.'s nomination to lead HHS as "medical malpractice on a mass scale," joining former FDA Commissioner Scott Gottlieb in urging Senate Republicans to reject the president-elect's controversial pick. Their remarks signal an effort to derail Kennedy's nomination ahead of the Senate's return from its Thanksgiving break, when Kennedy is expected to begin meeting with senators to lobby for his confirmation... Sub. Req’d

How Republican 'Red Wave' in Washington Could Shake Up Healthcare, Pharma Policy: S&P

(12/3, Heather Landi, Fierce Healthcare) ...With the incoming Trump administration and a Republican-controlled Congress, significant policy shifts are expected for the healthcare industry, from changes to the Affordable Care Act (ACA), the tone at the Federal Trade Commission (FTC) on M&A and tariffs and the priorities of the new head of Department of Health and Human Services (HHS)...Analysts with S&P Global Ratings don't expect a major ratings impact for healthcare companies over the near to intermediate term, but anticipate changes will be a net negative for the industry from a credit perspective... Full

Impact of the Inflation Reduction Act On Biosimilar Pricing, Dispensing

(12/3, Brian Nowosielski, Drug Topics) ...On the most recent episode of Over the Counter, Steve Callahan, Senior Director of Advisory & Insights at MMIT, talked with us about biosimilars and the Inflation Reduction Act... Full

Medicare Talks Lowered Drug Prices Up to 42%, Study Finds

(12/3, Peter Sullivan, Axios Pro) ...Negotiated prices were 8% to 42% lower than the previous net prices before negotiation, the study found. That ranges from 8% for the diabetes drug Farxiga to 42% for another diabetes treatment, Januvia..."All products remained more expensive in the U.S. than in other countries," the study found, apart from insulin, whose price was reduced by manufacturers... Sub. Req’d

Podcast: How Mark Cuban is Disrupting Big Pharma and Taking On Politics

(12/3, Chris Cuomo, WGN Radio 720) ...Mark Cuban (entrepreneur, investor, and founder, Cost Plus Drugs) joins Chris Cuomo to discuss disrupting Big Pharma, lowering healthcare costs, and how transparency can fix the system. Cuban also responds to Megyn Kelly's criticism of his political views and shares his thoughts on polarization, ranked choice voting, and why innovation is key to solving America's biggest challenges... Full

Mark Cuban Explains His Battle Against Pharmacy Benefit Managers

(12/4, Hoag Levins, Penn LDI) ...In January, Forbes profiled Cuban and spotlighted how, in an incredibly short period of time, he has achieved a dramatic disruption of the U.S. prescription drug distribution market: "Two years in, Mark Cuban's company keeps shaking up the generic pharmaceutical space. It added another 1,000 medicines in December to the list of now 2,200 drugs it sells directly to patients. The firm now offers prescription drugs—mostly generics—to over 2 million members."..."This industry is the easiest industry I've ever disrupted," Cuban told Emanuel. "And all it took was transparency and just telling the truth."... Full

Bristol Myers Squibb Latest Drug Company to Sue HHS Over 340B Rebate Model

(12/3, Heather Landi, Fierce Healthcare) ...Bristol Myers Squibb became the latest large drugmaker to sue the federal government over a plan to change how it doles out drug discounts to hospitals...To start, BMS said it intended to implement the model exclusively as to its Eliquis blood thinner product starting in the spring of 2025. HHS rejected BMS's intended 340B rebate model in early November saying the proposal would be inconsistent with the statutory requirements for the 340B Program, which requires approval of a rebate model such as BMS has proposed... Full

340B Plan B: Pharma Pivots To Rebate Pricing Model After Pharmacy Restrictions Fall Short

(12/3, Cathy Kelly, Pink Sheet) ...Drug manufacturers are shifting 340B price concessions for some products upfront counts to back-end rebates, despite HRSA opposition. Some companies are limiting their new rebate models only to products with Medicare negotiated prices for now. Regulatory consultant Bill Sarraille predicted more rebate-model announcements and litigation are coming in 2025... Global Sub. Full

ACR Urges Congressional Leaders to Reform ‘Underwater' Biosimilar Reimbursement

(12/3, Healio) ...The group, which also includes the Arthritis Foundation and dozens of state and local rheumatology organizations, have dubbed themselves the Underwater Biosimilars Coalition. On Nov. 30, the coalition sent a letter to leaders in both the U.S. House of Representatives and the Senate expressing "grave concerns" about providers being reimbursed for less than they spend to administer some biosimilars in outpatient facilities under Medicare Part B, leaving them "underwater."... Full

"If You've Got Legitimate Suspenders, Don't Have an Unconstitutional Belt:" Federalist Society Panel's Take On Jarkesy and the Preserve Access to Affordable Generics and Biosimilars Act

(12/4, Kurt R. Karst, FDA Law Blog) ...The heightened discussion concerning Jarkesy and the Preserve Access to Affordable Generics and Biosimilars Act has even caught the attention of a Federalist Society panel. Indeed, in a recent Federalist Society-sponsored webinar, titled "Does Jarkesy Doom the Preserve Access to Affordable Generics and Biosimilars Act?," moderator Brian Pandya (Duane Morris LLP) hashes out the interplay between Jarkesy and The Preserve Access to Affordable Generics and Biosimilars Act with Matthew S. Hellman (Jenner & Block), William M. Jay (Goodwin Procter LLP), and Prof. Emily Michiko Morris (The University of Akron School of Law)... Full

California Voters Deliver Accountability to Health Care Providers Exploiting Drug Program

(12/3, Julie Gill Shuffield, Desert Sun) ...While the official vote won't be certified until next month, the results were clear enough to declare a victory for a California ballot initiative on health care, namely Proposition 34, an effort to make sure that drug sale revenue is used solely on health care. Prop. 34 confronts the longtime abuse of the federal 340B prescription drug program and will hold bad actors accountable if providers don't spend 98% of their revenue on patients. California voters got it right... Full

As ‘Carveout' Debate Continues, States Try Hybrid Approach to Medicaid Rx Benefits

(12/3, Leslie Small, Pink Sheet) ...Some states are implementing hybrid approaches to pharmacy benefits management, where managed care organizations are paid to provide pharmacy benefits, but must contract with a single pharmacy benefit manager. Kentucky touted the savings produced by the move and now eight states have implemented similar systems. But finding proof that the program is beneficial can be difficult... Global Sub. Full

English NHS Failing to Meet Targets For Availability Of NICE-Approved Cancer Drugs

(12/3, Leela Barham, Pink Sheet) ...An analysis of the time to first treatment for anticancer drugs made available under the UK Early Access to Medicine Scheme (EAMS) and OK'd by England's health technology assessment body NICE has found that the National Health Service has only rarely been able to achieve the aim of availability in 30 days. There is reason for optimism though, according to the analysis conducted by the Pink Sheet: availability has been getting faster over time for both EAMS and non-EAMS treatments... Global Sub. Full

EMA PRIME Scheme: Two New Entries, 10 Rejections & One Withdrawal

(12/3, Neena Birzmohun, Pink Sheet) ...A total of 141 products have made it onto the European Medicines Agency's PRIME (priority medicines) scheme since 2016 and over 370 applications have been denied entry...The fact that a medicine is not accepted in PRIME does not mean that its development should not be pursued. As previously noted by the agency, "medicines that are not granted PRIME access can still benefit patients by providing alternative treatment options for a disease."... Global Sub. Full

UK MHRA Reminds Industry Of Looming Deadline For New Packaging Requirements

(12/3, Eliza Slawther, Pink Sheet) ...More than 90% of companies have submitted new medicines packaging artwork to the UK's drug regulator, the MHRA. The agency urges the remaining marketing authorization holders of its December 31, deadline to comply with the new Windsor Framework arrangements... Global Sub. Full

MHRA's Stature Undermined by Lack of Resources Says Pharma

(12/4, Phil Taylor, PharmaPhorum) ...The Association of British Pharmaceutical Industry (ABPI) warns in the document that lack of resources, and the knock-on effect of struggling to attract and retain top talent, have undermined the MHRA's standing as a global regulator and – as a consequence – threatens the UK's competitiveness in life sciences. It has urged the MHRA's new chair Professor Anthony Harnden and its new chief executive – when appointed – to take steps to restore the agency's standing after a difficult few years navigating the changes forced by Brexit, the COVID-19 pandemic, and an ongoing restructuring drive... Full

India Regulatory Reform: ‘Redeliberation' At SECs Tightened, ‘Unnecessary Load' Reduced

(12/3, Anju Ghangurde, Pink Sheet) ...Addressing the annual summit of the Organisation of Pharmaceutical Producers of India (OPPI), Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), outlined certain initiatives that the regulator is implementing to ensure optimal use of resources, while also seemingly tightening some processes around areas like clinical trial clearances. The OPPI essentially represents the interests of foreign firms in India... Global Sub. Full

Japanese Drug Market Prices 5.2% Lower Than Official Prices

(12/4, The Japan Times) ...Market prices of drugs purchased by medical institutions from wholesalers in Japan were 5.2% lower than the state-set official prices on average as of September, a health ministry survey showed Wednesday. Based on the survey results, presented to a relevant panel advising the health minister, the government plans to lower official drug prices for fiscal 2025 while carefully considering the scope of items subject to the planned cuts in light of the impacts on drugmakers... Full

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Thursday, December 5, 2024

Teva Reports Positive Outcomes from Episodic Migraine Trial in Young Patients

(12/5, Clinical Trials Arena) ...Teva Pharmaceutical Industries has reported positive outcomes from its multicentre Phase III SPACE trial of Ajovy (fremanezumab) as a preventive treatment for episodic migraine in young individuals aged six to 17 years... Full

Fremanezumab for Episodic Migraine Prevention Demonstrates Positive Phase 3 Data

(12/4, Joshua Fitch, Contemporary Pediatrics) ..."Over the last 30 years, the incidence of childhood migraine has increased but there has been little innovation in licensed treatments to manage this debilitating condition in children." Eric A. Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva Pharmaceuticals, said in a statement..."We've already seen the benefits of [fremanezumab] in adults and the SPACE trial has confirmed that children with episodic migraine can also benefit from [fremanezumab]. This is a significant step forward for the care of migraine in children and adolescents who are having to live with this high burden," said Hughes... Full

Teva Presents Positive Data from Ajovy Pediatric Study

(12/4, Val Brickates Kennedy, Seeking Alpha) ...The Israeli drugmaker said the study showed Ajovy significantly reduced the monthly migraine days and monthly headache days versus placebo in children aged six to 17 over a 12-week period. Teva said the efficacy results were consistent with those from Phase 3 and real-world evidence studies in adults, with no new safety signals observed, according to a statement... Full

AstraZeneca's New EVP of International Amid China Investigation; Janux's $300M Offering

(12/4, Endpoints News) ...Teva's Ajovy bests placebo in pediatric migraine trial: Over 12 weeks, Ajovy "significantly" reduced monthly migraine days and monthly headache days compared to placebo in patients between six and 17 years old. The full data are set to be presented at the European Headache Congress in the Netherlands this week... Full

Piper Sandler Reiterates Overweight On Teva Pharma (TEVA) as Management Provides Updates

(12/5, StreetInsider.com) ...[David Amsellem] "...That said, the commentary from the team regarding other critical parts of the business (e.g., visibility into the expansion of the Austedo franchise; the operating leverage associated with layering in other neuropsychiatry-focused brand assets (particularly Teva's long-acting injectable antipsychotics); a growing biosimilars footprint, helping drive stability for the U.S. generics segment; organic brand pipeline advancement (e.g., the advancement of emrusolmin into Phase II in multiple system atrophy)) reinforces our view that further multiple expansion is warranted (from a current EV/2025E EBITDA of ~7x, and in the context an improving capital structure). We reiterate our Overweight rating and $23 PT."... Sub. Req’d

Teva: Becoming Increasingly Solid, But No Longer Undervalued

(12/4, Eugenio Catone, Seeking Alpha) ...Teva's stock has risen 105% in two years, outperforming the S&P 500, but it is no longer a bargain at $17.50 per share. The company's focus on debt reduction has been successful, with net debt falling to $15.70 billion, but high interest expenses remain a concern. Key drugs like AUSTEDO®, AJOVY®, and UZEDY® are driving revenue growth, with AUSTEDO® showing the most promise due to long patent life and rising demand. Despite strong performance and growth in generics and biosimilars, I recommend holding Teva stock, valuing it at $15 per share... Full

Goodbye Biosimilars: Coherus Sells Udenyca To Intas For Half A Billion

(12/4, Dave Wallace, Generics Bulletin) ..."By adding Udenyca to our growing portfolio of biosimilars, we will strengthen our business footprint in the US," commented Chrys Kokino, US president of Accord. "With an expanding presence in the market, we can fuel the internal innovation and external expansion needed to deliver more accessible treatment options to patients."... Global Sub. Full

Richter Eyeing 20%+ Margin On Denosumab As Part Of 2027 Profit Plans

(12/4, Dean Rudge, Generics Bulletin) ...Gedeon Richter is feeling good about its plan to launch a biosimilar denosumab product in the EU in 2025, as it continued to slow down losses for its biopharma unit ahead of plans to swing to profitability later in the decade. Gedeon Richter says that if its European denosumab filing continues along its current trajectory, "there's a high probability that we can launch on time and have a relatively short approval process, which gives hope that the denosumab launch taking place next year will be successful."... Global Sub. Full

US Market Opens Up For Henlius After First Shipment

(12/4, Dave Wallace, Generics Bulletin) ...Noting that "the US, as the world's largest biopharmaceutical market, imposes stringent requirements on drug supply systems and the comprehensive strengths of companies," Henlius president Wei Huang said "the successful entry of Hanquyou into the US market not only expands our international footprint but also lays a solid foundation for the globalization of our other products."... Global Sub. Full

GSK to Get Less from Zhifei Shingles Vaccine Deal; To Collaborate On RSV

(12/5, Yadarisa Shabong, Reuters) ...China's Zhifei will pay GSK about 2.3 billion pounds ($2.9 billion) for the exclusive rights to distribute GSK's shingles vaccine in China, the UK drugmaker said on Thursday, lower than previously agreed though the deal has been extended. The deal also now includes exclusive rights for China's largest vaccine company to explore a collaboration on GSK's respiratory syncytial virus (RSV) vaccine, Arexvy, in China, the world's No.2 pharmaceuticals market, for an initial term of 10 years... Full

Novartis Cannot Block Generic of Best-Selling Heart Drug, US Appeals Court Says

(12/4, Blake Brittain, Reuters) ...The U.S. Court of Appeals for the Federal Circuit upheld a Delaware federal judge's August decision that found Novartis failed to prove it was likely to win a patent lawsuit against MSN over the drug, removing a roadblock for MSN's launch of what would be the first U.S. Entresto generic. Novartis said in a statement that it disagrees with the ruling and is "considering all available options to vigorously defend our intellectual property rights, including further appellate options."... Full

Dr Reddy's Will Top Up Base Business with Innovation in India: M V Ramana

(12/4, G Naga Sridhar, The Hindu BusinessLine) ...After being one of the major players in the US and European markets, pharma major Dr Reddy's Laboratories is now keen on ramping up its position in the domestic market with a slew of measures. Out of a total revenue of 27,916 crore, its India business logged 4,640 crore in FY24. businessline spoke to M. V. Ramana, CEO, Branded Markets (India & Emerging Markets), Dr. Reddy's Laboratories on the company's plans... Full

Celltrion Starts Production at New Songdo Plant

(12/5, Hwang Joo-young, The Korea Herald) ...South Korean biopharmaceutical firm Celltrion announced Thursday that its third plant in Songdo, Incheon, has officially commenced commercial production, following the completion of a performance qualification test...Celltrion stated that the third plant focuses on small-batch production of multiple drug substances for its products, enabling the company to respond quickly to market demands and changes. The company also aims to maximize cost efficiency through high-titer technology, which increases output from the same volume of culture medium... Full

Aurobindo Pharma Wins USFDA Approval for Generic Cancer Drug

(12/5, Anupama Ghosh, The Hindu BusinessLine) ...Aurobindo Pharma Limited announced today that its subsidiary Eugia Pharma Specialities Limited has received US Food & Drug Administration final approval to manufacture and market Pazopanib Tablets, 200 mg...The generic drug is bioequivalent to Novartis Pharmaceuticals' Votrient Tablets and is indicated for treating advanced Renal Cell Carcinoma (RCC) and Soft Tissue Sarcoma (STS) in adult patients who have undergone prior chemotherapy... Full

UnitedHealthcare CEO's Killing Lays Bare Rising Security Risks Facing Health Care Leaders

(12/5, Annalisa Merelli and Jonathan Wosen, STAT) ...In recent years, the threat level seems to have risen for health care executives. Following the backlash against Covid-19 vaccines, Moderna and Pfizer began spending significantly on the personal safety of their leadership...Thompson's wife, Paulette Thompson, told NBC News her husband had received threats. The New York Police Department said in a press conference on his killing that, based on an initial assessment, he didn't appear to be traveling with a security detail. UnitedHealth did not comment on the company's security measures. NYPD officials said the killing appeared to be targeted, but they have not identified a motive or named a suspect... Full

UnitedHealth CEO's Killing Unleashes Social Media Rage Against Insurers

(12/5, Maya Goldman, Axios) ...Wednesday's shocking murder of UnitedHealthcare CEO Brian Thompson unleashed a wave of social media-fueled rage against health insurers, with posters lashing out over coverage denials and other business practices...Experts say the lack of sympathy may reflect an inherent truth about Americans and their health plans: People tend to like their own insurer but distrust the industry — and indeed, the health system at large... Full

Battling Big Pharma: A Conversation with Mark Cuban

(12/4, Wired) ...His time on Shark Tank may be over, but this serial investor is just getting started. The Cost Plus Drugs founder shares how he's demolishing–and rebuilding–the prescription drug industry with WIRED's Lauren Goode... Full

This CEO Sells Low-Cost Drugs, and He Says Big Pharma Might Not Be The True Adversary

(12/4, Robert Safian, Fast Company) ...Cost Plus Drugs CEO Alex Oshmyansky explains his hopes for helping to change healthcare for the masses on the latest episode of the "Rapid Response" podcast...With the help of co-founder Mark Cuban, CEO Alex Oshmyansky is radically re-engineering the pharma marketplace and dramatically cutting the price for many prescription drugs. Oshmyansky shares why Big Pharma might not be the true adversary, how Y Combinator got his company off the ground, and his hopes for helping to change healthcare for the masses... Full

U.S. Patent Office Pulls Controversial Rule to Curb Pharma Patent Abuse

(12/4, Ed Silverman, STAT Plus) ...Specifically, the proposed rule was crafted to stem the use of so-called patent thickets, which are wielded by drug companies to delay the arrival of lower-cost generic medicines in the marketplace. Essentially, thickets are collections of numerous patents that critics contend add only incremental changes to a drug and, therefore, produce little to no additional benefit to patients....As for industry, the Pharmaceutical and Research Manufacturers of America, a trade group that represents brand-name drug companies, wrote in its own comment that the rule would "negatively impact incentives for innovation for PhRMA's member companies. This in turn could have negative implications for future life-saving and life-enhancing therapies for patients in need."... Sub. Req’d

CSRxP: USPTO Withdrawal of Patent Thicket Rule Adds to Urgency for Congress to Pass Cornyn-Blumenthal

(12/4, The Campaign for Sustainable Rx Pricing) ..."We are disappointed in USPTO's decision to withdraw this proposed rule, which adds even greater urgency to the need for Congress to crack down on Big Pharma's egregious patent thickets by passing Cornyn-Blumenthal in the lame duck," said CSRxP executive director Lauren Aronson. "Big Pharma's patent thickets protect drug company profits not innovation, while keeping drug prices high for millions of American patients."... Full

Reminder: "Delinking" Is Pharma's Top Priority Because It Boosts Their Profits

(12/4, PCMA) ...A research paper, "Ending Pay for PBM Performance: Consequences for Prescription Drug Prices, Utilization, and Government Spending," from University of Chicago Professor of Economics Casey Mulligan, Ph.D, and published by the National Bureau of Economic Research, examined the consequences of "delinking" in Medicare Part D. According to the report, such a policy would undermine incentives for pharmacy benefit companies to maximize competition in the market and secure savings for patients and health plan sponsors, resulting in higher drug prices and handing drug companies a profit-boosting windfall... Full

Murphy Urges Congress to Take Action Against Pharmacy Benefit Managers

(12/4, U.S. Congressman Gregory F. Murphy, M.D.) ..."The Lower Costs, More Transparency Act, which has received bipartisan, bicameral support, directly addresses these concerns by making health care more affordable for patients and employers through increased transparency and competition. Unfortunately, Senate Majority Leader Chuck Schumer held it up for almost a year. This is unacceptable, and I will keep fighting until we get it signed into law."... Full

Policy Proposals Aim to Stimulate the Long-Term Sustainability of Infused Biosimilars

(12/4, Cameron Santoro, AJMC) ...Proposed policy solutions include increasing ASP-based reimbursement, shared savings models, and adjusting rebate calculations to enhance biosimilar uptake. The Inflation Reduction Act may impact Medicare's ASP payments, promoting biosimilar use over brand-name drugs... Full

Editorial: RFK Jr.'s Race Against the Cure

(12/5, The Wall Street Journal) ...Conservatives who support Donald Trump's choice of Robert F. Kennedy Jr. to lead the Health and Human Services Department say he will disrupt the healthcare bureaucracy. They may be right. But he could also disrupt access to life-saving medicines and the innovation ecosystem that creates them... Sub. Req’d

Trade Group Tells FDA that Semaglutide is Not Too 'Complex' for Compounding

(12/4, Nicole DeFeudis, Endpoints News) ...The Alliance for Pharmacy Compounding told the FDA last week that Novo Nordisk's weight loss medicine semaglutide is not too difficult to compound, pushing back against the Danish pharma's arguments that seek to limit pharmacies from making their own versions of the blockbuster drug...A Novo spokesperson told Endpoints News Wednesday that its intention is "keeping people safe from unapproved and potentially harmful versions of knock-off ‘semaglutide' drugs."... Full

AMA Urges Policymakers to Act Despite Report of Improved Opioid Epidemic

(12/4, Brian Nowosielski, Drug Topics) ...According to AMA's 2024 Overdose Epidemic Report, naloxone is being dispensed more often, prescription drug monitoring programs have increased, opioid prescriptions have decreased, and the number of buprenorphine prescriptions dispensed is currently plateauing. But despite seeing efforts to combat the opioid crisis finally come into fruition, the AMA is pressuring policymakers to strive for an end to this epidemic before it has the chance to worsen... Full

US FDA Generic Drug Approvals, Other Actions Declined As Approval Times Climbed In FY 2024

(12/4, Derrick Gingery, Pink Sheet) ...Full ANDA approvals dropped in FY 2024, compared to the previous year, while submissions increased slightly. Complete response letters also dropped, but quarterly mean and median approval times increased. The data may help shape the upcoming user fee reauthorization negotiations, which will begin in 2025... Global Sub. Full

New Task Force Looks to Bring Down Prescription Drug Prices

(12/5, Mike Savino, NBC Connecticut) ...The task force won't provide recommendations before the legislature returns to the Capitol on Jan. 8, but lawmakers hope to have proposals sometime this spring. They invited drug manufacturers and pharmaceutical benefit managers, professionals who negotiate drug prices, to join the task force. "PBMs can and should lower costs by 50% or more by sharing rebates provided by manufacturers with patients, yet they choose to charge you full price at the pharmacy counter," Pharmaceutical Research and Manufacturers of America spokesperson Stami Turk said in a statement... Full

Bills to Reduce Insulin and Other Prescription Drug Costs Return to the California Legislature

(12/4, Megan Myscofski, CapRadio) ...Assembly Speaker Robert Rivas framed California's new legislative session as a chance to increase affordability for people struggling financially. "I'm calling on us to consider every bill this session through their lens," said Rivas, a Democrat from Salinas, in a speech at the state Capitol this week. In response, Democratic Senator Scott Wiener of San Francisco reintroduced two bills meant to cut down drug costs... Full

2024 Regulatory Policy Forum Takes an In-Depth Look Into the "Once in a Generation" Changes to the EU Pharmaceutical Legislation

(12/4, Regulatory Focus) ...Discussions centered on the need for strategic planning, change management, sufficient piloting of new approaches, and the development of robust guidance, expertise, and resources to enable effective operation from Day 1 of the new framework... Full

Why Historical Data Will Be Important Under The New EU HTA Regulation

(12/4, Eliza Slawther, Pink Sheet) ...The incoming EU Health Technology Assessment Regulation will see historical data move "more center stage" for advanced therapies, because directly comparing highly individualized therapies is often unfeasible, an advanced therapies expert says... Global Sub. Full

UK Pharma Group Calls for Regulatory Reform

(12/4, The Pharma Letter) ...A new report from the Association of the British Pharmaceutical Industry (ABPI) lays out a roadmap for the agency to: "regain its world-class reputation," calling for more resources and the adoption of flexible licensing routes. Richard Torbett, chief executive of the ABPI, said: "This report sets out a clear roadmap for the MHRA's incoming leadership to ensure the UK can operate as a leading authority that supports the development of new medicines and can safely and swiftly bring new innovations and treatments to patients."... Sub. Req’d

Britain Drug-Cost Watchdog Says It Will Recommend Lilly Obesity Drug

(12/5, Maggie Fick, Reuters) ...Britain's drugs cost-effectiveness watchdog NICE said on Thursday it will recommend Eli Lilly's obesity drug Mounjaro be made available to around 220,000 people in the country via the state health system over the next three years... Full

Pharma Exports Prompt Denmark to Raise 2025 Growth Forecast

(12/5, Sanne Wass, Bloomberg) ...The Danish economy will expand faster next year than previously estimated, boosted by exports from drugmakers including Novo Nordisk A/S, the government forecast. Gross domestic product growth will probably come in at 2.9% next year, more than the 2.2% forecast published in August, the Economy Ministry said in a report on Thursday. The government also raised its estimate for this year's growth to 3.0%, from 1.9% seen before... Full

Canadian HTA Agency Consults On First Methods Guideline

(12/4, Francesca Bruce, Pink Sheet) ...A new methods guide from Canada's health technology assessment agency should help drug sponsors generate and report appropriate clinical evidence. Canada's Drug Agency (CDA), the national health technology assessment body, is seeking feedback on its first ever methods guide in a bid to improve transparency and understanding of its work, and to explain the types of evidence that can help show a product's comparative effectiveness... Global Sub. Full

India's Pharma Future Relies On Regulatory Strength

(12/5, Shreeyashi Ojha, BioProcess International) ...The Indian pharmaceutical industry, historically known for its dominance in the production of small molecules, is poised to establish itself as a major supplier in large molecule and biologics space. Coinciding with the country's centenary of independence, the Government of India aspires to reach a $500 billion valuation for the pharmaceutical industry by 2047. Although currently valued at $65 billion, the sector is projected to reach $120 billion to $130 billion by 2030... Full

Enhertu Among Drugs In Annual China NRDL Update

(12/5, Xu Hu, Pink Sheet) ...China's National Healthcare Security Administration (NHSA), the government agency that oversees health insurance schemes and organizes annual negotiations of drug prices, released on November 28, the updated 2024 National Reimbursement Drug List (NRDL), marking the seventh time this has been updated since the agency was established in 2018. The list will take effect on January 1, and the new inclusions bring the total number of reimbursed drugs under the list to 3,159... Global Sub. Full

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