Thursday, January 4, 2024

Analysts Bullish On Teva

(2/6, Shiri Habib-Valdhorn, Globes) ...More and more analysts are expressing confidence in the stock of Teva Pharmaceutical Industries Ltd.. Data from "The Wall street Journal" shows that just three months ago the analysts' consensus on Teva's share was neutral, whereas today it is positive. The Israeli pharmaceutical company, managed by CEO Richard Francis, published its financial results last week for the fourth quarter of 2023 and full-year 2023, in which it returned to growth after five years of shrinking revenue, and according to its 2024 forecast, growth will continue this year... Full

‘I'm Fed Up': Frustrations Grow As ADHD Drug Shortage Continues

(2/6, Berkeley Lovelace Jr., NBC News) ...Drugmakers have published estimates of when the medications will be back in stock, but as they struggle with demand, those estimates have been pushed back. Aurobindo Pharma, which makes a generic version of Adderall, for example, estimated in June that some doses of the drug would be available in December, only for the timeline to be pushed back several months, to September, according to the FDA drug shortage database. Teva Pharmaceuticals, a major manufacturer of ADHD medications, did resolve many of its Adderall shortages. However, certain doses estimated to be available in October or December have been pushed back to February or May, according to the database... Full

Millions of Americans Face Prescription Medication Shortages

(2/6, Timothy Moore, USA Today) ...As a result of medication shortages, patients are rationing medicines, delaying prescriptions, buying more expensive substitute meds or suffering from physical and mental conditions that are otherwise treatable. We analyzed data from the two most recent United States Census Bureau Household Pulse Surveys and discovered that 14.6% of respondents were affected by prescription medication shortages, which amounts to more than 62 million people... Full

AbbVie Sets Out Expectations For 2024 Humira Competition

(2/7, David Wallace, Generics Bulletin) ...Despite such a significant drop in sales for Humira in 2023, AbbVie is happy with the way it has handled biosimilar competition for its once-flagship brand. Speaking at the annual J.P. Morgan Healthcare Conference in January, the company's president and chief operating officer Robert Michael said US Humira erosion had "gone exceptionally well," with contracting for 2024 indicating that the brand was "going to have more parity access than we initially anticipated."... Global Sub. Full

Torrent Pharma Says Company at a New Stage of Profitability

(2/7, Sreejith Rajan, The New Indian Express) ...Torrent Pharmaceuticals, one of India's top drugmakers, has said that it expects a 'new base' for its profitability going forward, given that several of its overseas operations have outgrown the investment stage. Over the last two years, the company's profit margin from its operations has improved from around 27% to 31.8%, both due to cost cuts as well as better revenue. What's more, the company expects its profit margin to improve by 0.5 to 1.0 percentage points every year... Full

USFDA Gives Nod to Lupin's Generic Formulation to Treat Ocular Pain

(2/7, Financial Express) ...Global pharma major Lupin Limited on Tuesday announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.075 percent... Full

Gilead Quarterly Revenue Drops 4%, Oral COVID Drug Fails Trial

(2/6, Deena Beasley, Reuters) ...Gilead Sciences on Tuesday said fourth-quarter revenue dipped 4% on lower sales of HIV drugs and its infused COVID-19 treatment Veklury, and the company forecast weaker-than-expected 2024 sales... Full

Lilly Rides Wave of Weight-Loss Drug Demand, Working to Expand Capacity

(2/6, Patrick Wingrove and Bhanvi Satija, Reuters) ...Eli Lilly on Tuesday forecast 2024 profit above Wall Street estimates on soaring demand for Zepbound, its recently approved weight-loss drug, and said the treatment helped reduce symptoms of a common, difficult to treat fatty liver disease in a mid-stage trial. Explosive demand for diabetes treatment Mounjaro, which had also been used off label for weight loss, and now Zepbound, has led to a buying spree of Lilly's stock, propelling the drugmaker's market value to over $600 billion... Full

Samsung Biologics Signs ADC CDO Deal With LegoChem Bio

(2/7, Dae-Kyu Ahn, The Korea Economic Daily) ...Samsung Biologics Co. has agreed with South Korean biotech company LegoChem Biosciences Inc. to provide contract development organization services for the development of antibody-drug conjugate therapies...With the latest deal, Samsung Biologics will accelerate its inroads into the ADC contract development and manufacturing organization market... Full

Jazz Buys KRAS Inhibitors from Redx in $880M Deal

(2/7, Phil Taylor, PharmaPhorum) ...Under the terms of the deal, Jazz will acquire Redx's KRAS inhibitor programme outright, including multiple preclinical-stage drug candidates, and will take responsibility for ushering the most promising compounds through clinical trials and onto the market. There's another $870 million on offer tied to the achievement of development, regulatory, and sales milestone payments in addition to royalties on future net sales... Full

Hikma To Pay Up $150M In US Opioid Settlement Framework

(2/7, Urt Fultinaviit, Generics Bulletin) ...Despite denying any wrongdoing, Hikma joins a group of companies that have agreed to pay big settlements for their alleged respective roles in the ongoing opioid epidemic in the US...Hikma is one of many companies that have faced settlements as a result of the opioid epidemic in the US. Last year, the Israeli company Teva fully resolved its nationwide US settlement by agreeing to terms with "all 50 states and 99% of litigating subdivisions"... Global Sub. Full

GoodRx Bets On Working With Pharmacies As Prescription-Drug Reimbursement Pressure Grows

(2/6, Lydia Ramsey Pflanzer, Endpoints News) ...The change at GoodRx comes as healthcare giants like Cigna and CVS Health are exploring new ways to pay for prescription drugs in which PBMs reimburse pharmacies at a rate including a set markup, the drug's cost and a service fee. It's a similar model to billionaire Mark Cuban's Cost Plus Drug Company, which charges for medication based on a 15% markup off the wholesale price of the medication plus pharmacy fees. Jim Sheninger, pharmacy strategy officer at GoodRx, said the company has seen increasing interest from pharmacies, in particular in setting up contracts to set prices on certain drugs... Full

Biosimilar Etanercept Similar to Enbrel in Persistence of Treatment, Cost Savings for Patients With RA

(2/6, Cameron Santoro, The Center for Biosimilars) ...An Australian study found the persistence of treatment was similar between the etanercept originator (ETN; Enbrel) and the biosimilar SB4 (Brenzys) treatment groups for patients with rheumatoid arthritis, while considering the potential cost-savings implications... Full

Behind Generic Drug Shortages, House Committee Points to Lackluster Manufacturing and High Prices

(2/6, Anna Brown, Endpoints News) ...The seesaw between questionable generic drug manufacturing and rock bottom prices took the spotlight at a House Ways and Means Committee hearing on chronic drug shortages Tuesday morning. "Poor manufacturing quality is the leading driver of chronic shortages and it's the most preventable," Committee Chair Jason Smith (R-MO) said at the start of the hearing...New legislation was proposed during the meeting by Jeromie Ballreich, an associate research professor at Johns Hopkins Bloomberg School of Public Health. The legislation explains how transparent drug production is needed - manufacturers should disclose information such as facility capacity and sources of raw materials... Full

Drug Shortages May Mean Difference Between Life and Death for Some US Patients, Experts Say

(2/6, Jen Christensen, CNN) ...Dr. Julie Gralow, chief medical officer and executive vice president at the American Society of Clinical Oncology, told the House committee Tuesday that shortages put providers in a terrible place. "The drug shortage crisis is forcing providers to make impossible choices," she said. Gralow said it's also stymied new drug development, since scientists need these older medications to compare with new drugs in clinical trials. Transparency was among her recommendations... Full

Experts Urge Congress to Combat U.S. Drug Shortage by Requiring Transparency

(2/6, Emma Sullivan, UPI) ...Lawmakers on the House Committee for Ways and Means called on manufacturers Tuesday to improve transparency as the United States experiences a nationwide drug shortage...Allan Coukell called on Congress during his testimony to evaluate manufacturing quality and consider policies that encourage suppliers to maintain additional buffer inventory beyond immediate demand. "After a dozen years, [drug shortages] must now be understood as a built in and permanent outcome of the current system," said Coukell, the senior vice president for public policy at Civica Rx, a non-profit pharmaceutical company... Full

Drug Shortages Aren't Over. And There's Little Progress Toward Ending Them

(2/7, Tyler Patchen, BioSpace) ...While new manufacturers are coming online and President Biden has made clear his intentions to fortify the supply chains through government action, experts agree that shortages may persist for some time. "The generics market is in crisis, and it would not be surprising to see more shortages due to product discontinuations caused by bankruptcies, plant closures and individual company decisions that they can no longer afford to supply a drug," Vimala Raghavendran, the vice president of Informatics Product Development at US Pharmacopeia, told BioSpace... Full

Sanders Looks to Harness Outrage On Drug Prices

(2/6, Peter Sullivan, Axios) ...Two of the CEOs, Johnson & Johnson's Joaquin Duato and Merck's Robert Davis, declined to testify until Sanders threatened to subpoena them, and might not be eager to make many promises. Bristol Myers Squibb's Chris Boerner agreed to appear before the subpoena threat. Raymond James analyst Chris Meekins said there is not likely to be much substantive impact, barring a major gaffe from the CEOs in front of the cameras... Sub. Req'd

With Merck, J&J and BMS CEOs Set to Testify, Sanders Releases Scathing Report On Drug Prices

(2/6, Kevin Dunleavy, Fierce Pharma) ...Two days ahead of a Senate hearing in which CEOs from three pharma majors will testify, Sen. Bernie Sanders, I-Vermont, has released a report shedding light on the system that allows the companies to charge more for drugs in the U.S. than in any other country. The report, from the Senate Committee on Health, Education, Labor and Pensions, zeroes in on the three companies that will be under fire on Thursday. Scheduled to appear are CEOs Chris Boerner of Bristol Myers Squibb, Joaquin Duato of Johnson & Johnson and Robert Davis of Merck & Co... Full

CMS Lays Out Timeline For Biosimilar's Effect On Stelara's IRA Pricing

(2/6, Maaisha Osman, InsideHealthPolicy) ...A CMS official laid out how the timing of the agency's determination that Amgen is marketing its biosimilar Wezlana leads to differing scenarios for when Johnson & Johnson could get around Medicare's upcoming negotiated price for Stelara, the brand version of the arthritis and psoriasis drug... Sub. Req'd

House Panel Passes Key PBM Reform for Sliver of Commercial Market

(2/6, John Wilkerson, STAT Plus) ...A House panel passed a bipartisan bill to ban drug middlemen from charging fees based on drug list prices — the first in Congress' raft of PBM reform efforts that would actually ban the practice in at least some of the employer-sponsored insurance market... Sub. Req'd

FTC Calls for ‘Expansive and Flexible' Use of March-In Rights to Rein in Drug Prices

(2/6, Angus Liu, Fierce Pharma) ...As the U.S. Department of Commerce works to finalize draft guidance around the government's so-called "march-in" rights to step on drug patents, the Federal Trade Commission has offered its support in the name of promoting competition in the biopharma market...As for the "flexible" quality that the FTC seeks, the antitrust enforcer says U.S. agencies "should be wary of imposing categorical limitations on the factors that can be considered for march in, such as price." Pricing may be one of a myriad of factors for consideration, the agency contends... Full

Biden Drug Patent Plan Poses Economic Threat, Pharma Lobby Says

(2/6, Ian Lopez, Bloomberg Law) ...The Biden administration's proposed framework to "march in" on government-funded patents because the drugs they cover are too expensive would threaten the US pipeline of investments and innovation, the Pharmaceutical Research and Manufacturers of America said Tuesday. "The negative effects of the Draft Framework could have a ripple effect throughout the innovation ecosystem, ultimately reducing investment in small biotech companies and in the development of university inventions, and jeopardizing future benefits to the U.S. economy," PhRMA said... Sub. Req'd

If Congress Is To Take Drug-Pricing Seriously, It Should Focus On PBMs

(2/7, Daniel Savickas, RealClearMarkets) ...Prescription drug pricing has a very odd and confusing structure. Market-based pricing isn't a feature of the current system. And, what people may not understand is that pharmacy benefit managers are also re-imbursed in a very strange manner. PBMs are currently paid based on the size of the discount they achieve for insurance companies – and, therefore, the employers who offer these insurance plans to their employees. While this seems straightforward, it actually creates upward pressure on prices for patients and families... Full

Welch Hosts Capitol Hill Briefing With Patients and Experts On Big Pharma's Efforts to Block Competition Through Patent Thickets

(2/6, U.S. Senator for Vermont Peter Welch) ...Today, Sen. Peter Welch (D-Vt.) hosted a panel discussion with Sen. Amy Klobuchar (D-Minn.), health care experts, and patient advocates, focused on Big Pharma's use of so-called patent ‘thickets' to prevent generic and biosimilar drugs from entering the market, and the harmful impacts of patent thickets on everyday patients. The discussion focused on new bipartisan, bicameral legislation Sens. Welch and Klobuchar introduced with Sen. Mike Braun (R-Ind.) to streamline prescription drug patent litigation, encourage fair market competition, and lower prescription drug prices... Full

HHS Backs NIH Rejection Of Xtandi Petition Despite March-In Framework

(2/6, Gabrielle Wanneh, InsideHealthPolicy) ...HHS Secretary Xavier Becerra is standing behind the National Institutes of Health's decision to reject a petition for the government to invoke its right to march-in on the patents of the prostate cancer drug Xtandi and have qualified generic drug makers make lower-cost alternatives of the drug, even though the Biden administration is on the cusp of considering costs as a credible factor for deciding when march-in rights should be used... Sub. Req'd

Universities Decry Biden's Plan for 'March-In' Rights as Disincentivizing Biopharma Partnerships

(2/6, Zachary Brennan, Endpoints News) ...A group of nonprofits representing major academic institutions and medical schools has come out against President Joe Biden's new framework to use "march-in" rights to reduce the price of some medicines developed with federal funds...The National Institute of Standards and Technology, which released the framework to more broadly use march-in rights, said it's received more than 50,000 comments so far. The Federal Trade Commission said earlier Tuesday that it supports the use of march-in rights as NIST outlines, "among other tools, to promote a competitive U.S. pharmaceuticals market and to ensure that taxpayer-funded innovations are accessible and affordable to the public."... Full

Renewed Congressional Focus On Patent Abuse Touts Proposals to Effectively Lower Prescription Drug Costs, Strengthen Competition in the Market

(2/6, PCMA) ..."We applaud and support the bipartisan, bicameral legislation to crack down on drug companies' patent abuse. For far too long, drug companies have engaged in anti-competitive tactics that keep more affordable alternatives, such as generics and biosimilars, off the market so that they can extend their product monopolies to boost profits. "Addressing the anti-competitive tactics egregiously and commonly used by drug companies is by far the most sure-fire way to actually reduce prescription drug costs for patients and employers”... Full

‘We Did Too Good Of A Job' On Lowering Prices: Sandoz's Haruvi Discusses Generic Sustainability

(2/6, M. Nielsen Hobbs, Pink Sheet) ...The Association for Accessible Medicines' annual meeting this year was in Tampa, Fla., and featured a nautical theme. Interim CEO David Gaugh appeared at the podium in a ship captain's outfit, and stage displays evoked waves. The concept seemed grimly fitting for an indistry that says it is struggling to stay above water. A white paper released at the conference is entitled "Hatch-Waxman turns 40. Is it over the hill? (Or is the Hill over Hatch-Waxman…)." The accompanying infographic notes that the historic legislation "brought down prescription drugs costs – but does it have a future?"... Sub. Req'd

AAM White Paper: Hatch-Waxman Turns 40

(2/6, AAM) ...The Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, today released a new report touting the lasting benefits the generic drug industry has provided to patients, employers and taxpayers in the forty years since the enactment of Hatch-Waxman, the landmark Drug Price Competition and Patent Restoration Act of 1984, but also the unprecedented challenges facing the industry calling into question the viability of sustainable competition from low-cost medicines... Full

How Trump Could Weaken Medicare Drug Pricing Negotiations

(2/7, Maya Goldman, Axios) ...Biden's and Trump's views on Medicare drug prices are "probably not that different," said Brian Blase, a former Trump policy adviser and president of Paragon Health Institute. But the people advising Trump would likely take a more friendly view of pharma...A Trump administration could loosen Medicare's interpretation of whether a drug has competition, which could result in more drugs being exempt from negotiations, said Joe Grogan, who led Trump's Domestic Policy Council... Full

Lawmakers Voice Concerns Over FDA's Foreign Inspection Program

(2/6, Mary Ellen Schneider, Regulatory Focus) ...The hearing of the House Energy and Commerce subcommittee on Oversight and Investigations focused on the frequency and quality of FDA's foreign drug inspections compared to domestic ones, and challenges to increasing in-person inspections overseas. "As long as foreign facilities remain uninspected, they pose a risk to quality and safety of life-saving medications that many Americans rely on," said Rep. Cathy McMorris Rodgers (R-WA) chair of the House Energy and Commerce Committee... Full

Lawmakers Hold FDA Foreign Inspection Practices Under Microscope at Hearing Without Agency Attendance

(2/6, Lia DeGroot, Endpoints News) ...Mary Denigan-Macauley, director for healthcare at the Government Accountability Office, said in her testimony Tuesday that the office warned the FDA about a backlog of inspections in 2021 and the agency has since drafted a plan to address them...The FDA says it did not receive a formal request to attend the hearing, with a spokesperson telling Endpoints News via email, "We understand the importance of our foreign inspection program to the health and safety of the American public and the agency has been responsive to the Committee's inquiries on this issue. We will continue to engage with any specific questions they have on this or related topics."... Full

HP&M Counsel John Claud Provides Testimony to House Subcommittee On FDA Foreign Inspections

(2/7, Kurt R. Karst, FDA Law Blog) ...In his remarks, Mr. Claud noted that FDA might make more efforts to gather evidence using technology. Teleconferences, document review, and other remote tools may not be a full inspectional cure for a bad actor, he said, but using remote inspections to "contribute to FDA's risk assessment" might allow the Agency to divert resources to other, more dire inspectional priorities that require an in-person presence... Full

New York Passes Legislation To Manufacture Own Generic Drugs

(2/6, Urte Fultinaviciute, Generics Bulletin) ...The New York State Senate has passed legislation in a bid to make prescription drugs more accessible and affordable for New Yorkers. The proposed legislation includes the "New York State Affordable Drug Manufacturing Act" that allows NYS to pursue its own manufacturing or partnering opportunities with like-minded states to reduce costs and drug shortages... Global Sub. Full

Canada Attacks Florida's ‘Bad' Bulk Importation Plan

(2/6, Francesca Bruce, Pink Sheet) ...The Canadian government and the R&D-based pharmaceutical industry have said that Florida's plan to bulk import medicines from Canada will fail to ease shortages in the US state and could cause or worsen supply problems north of the border. The industry trade group, Innovative Medicines Canada, says that the enforcement of 2020 legislation and reforms to the Food and Drugs Act will be "crucial" for protecting Canadian patients against shortages... Sub. Req'd

EMA Steps Up Support For Creation Of African Medicines Agency

(2/6, Ian Schofield, Pink Sheet) ...The European Medicines Agency says it will use a €10m ($10.75m) grant it received from the European Commission to increase its support for regulatory systems at national and regional level in Africa, and in particular for the creation of the African Medicines Agency (AMA). The money will be used to mobilize experts to support the AMA, its technical committees and African regulators in setting up the new agency's governance and its scientific and administrative processes... Sub. Req'd

Govt Departments Split As Trade Talks With European pharma Firms Hit Last Lap, Patent Key Issue

(2/7, Sumi Sukanya Dutta, The Print) ...Three of the key government departments involved in free trade agreement (FTA) negotiations with European countries appear to be not on the same page on provisions under discussion that directly relate to pharmaceutical products, ThePrint has learnt. India and the four countries that form the European Free Trade Association (EFTA) — Iceland, Liechtenstein, Norway, and Switzerland — are negotiating a Trade and Economic Partnership Agreement (TEPA), with an aim to boost economic ties... Full

Civil Society Groups Express Concern on Changes Proposed to Patent Rules, and Its Impact on Access to Medicines

(2/6, PT Jyothi Datta, The Hindu Business Line) ...An analysis of the proposed amendments reveals "that many of these changes would pose a significant threat to the fundamental Right to Health guaranteed under the Indian Constitution. This threat extends to a substantial number of individuals, both within India and beyond its borders," they wrote in a letter to the Minister. In August last year, the Department for Promotion of Industry and Internal Trade had proposed to introduce Amendments to the Patents Rules 2003... Full

Share of Cheap Drugs Rapidly Declining in Russia

(2/7, The Pharma Letter) ...The share of cheap drugs in the Russian pharmaceutical market is steadily declining, while in the last three years their overall range in the market has declined two-fold, reports The Pharma Letter's local correspondent. According to Russian pharma analytics agency DSM Group, in 2023, the overall range of drugs in Russian pharmacies fell by 11% compared to the previous year - from 21.600 to 19.400 trade items, and the decline is ongoing... Sub. Req'd

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