Tuesday, February 6, 2024

New Teva Ad Campaign Focuses On Patients Struggling With Psychiatric Drug Side Effect

(2/5, Nicole DeFeudis, Endpoints News) ...Teva is focused on growing its Austedo brand to treat tardive dyskinesia, a side effect of some mental health medications, jumpstarting this year with a new jingle and campaign driving patient awareness..."TD has a profound physical and emotional impact on people's everyday lives," Teva's senior VP of US innovative medicines Dell Faulkingham told Endpoints News on Monday. "We really wanted to create awareness and provide education."... Full

Teva Retains Perform Rating at Oppenheimer After 4Q23 Earnings Beat

(2/5, Rachael Rajan, Investing.com) ...On Monday, Oppenheimer maintained a Perform rating for Teva Pharmaceutical Industries Ltd., following the company's fourth-quarter earnings that surpassed expectations. The positive results were partly attributed to a $500 million payment from Sanofi for TL1A, which may not have been fully anticipated in market projections... Full

What a $200 Billion Blockbuster Drug Reveals About Big Pharma's Playbook

(2/5, David Wainer, The Wall Street Journal) ...As the drug company AbbVie began a new life of its own following a spinoff from Abbott Laboratories in 2013, it faced a challenge that would preoccupy newly minted Chief Executive Officer Richard Gonzalez for the next decade: how to avoid sales falling off as competition to its top blockbuster neared. Back then, the arthritis drug Humira was generating about $9 billion in annual sales, about half the company's revenue. Wall Street loved Humira's growth, but investors worried about the looming patent expirations... Sub. Req'd

Medicare Patient Access To Humira Biosimilars Still Falls Woefully Short

(2/5, Joshua Cohen, Forbes) ...According to a federal government Medicare Payment Advisory Commission report published last month, more than 40% of Medicare beneficiaries still have no access through their insurance to Humira-referenced biosimilars, despite several products having discounts of over 80% compared to the original Humira... Full

Astellas' Sales Expectations Are Up for Padcev, Down for Veozah

(2/5, Kevin Dunleavy, Fierce Pharma) ...Less than two months after the FDA approved the combination treatment of Astellas and Pfizer's Padcev and Merck's Keytruda in first-line bladder cancer, the Japanese company has raised its peak sales potential for its antibody-drug conjugate by 100 billion Japanese yen ($673 million). Astellas now estimates sales of Padcev to peak at between 400 to 500 Japanese yen ($2.7 billion to $3.4 billion), the company said on Monday in presenting its quarterly sales... Full

Alembic Pharma Q3 Results: Profit Up 48% as Raw Material Cost Declines

(2/5, Anjali Singh, Business Standard) ...Commenting on the same, RK Baheti, CFO Alembic Pharmaceuticals said, "Our 48 per cent increase in profit is attributed to making good money in the unpredictable US market. We focus on what's under our control – supply chain and compliances. The improvement at the Ebitda level is a result of both actual business improvement and lower tax provisions due to the impairment process." In the US Generics business, there was a 9 per cent Y-o-Y growth reaching Rs 474 crore, due to the introduction of 11 new products during the quarter and market share gain in recently launched and commercialised products... Full

Exclusive: Novartis in the Lead to Acquire Cancer Drug Developer MorphoSys-Sources

(2/6, David Carnevali, Reuters) ...Drugmaker Novartis AG said it will acquire MorphoSys AG, a developer of cancer treatments, for 2.7 billion euros ($2.9 billion), adding a promising rare bone-marrow cancer treatment candidate to its portfolio. Reuters first reported on Monday that Switzerland-based Novartis was in advanced talks to acquire MorphoSys, leading to the German biotech firm's shares surging more than 40%... Full

Celltrion's Partner Rani Therapeutics Releases Encouraging P1 Results for Oral Stelara Biosimilar

(2/6, Lee Han-soo, Korea Biomedical Review) ...Celltrion said that Rani Therapeutics has reported positive topline results from its phase 1 clinical trial of RT-111, an oral form of ustekinumab...Following these encouraging Phase 1 outcomes, Celltrion is set to discuss the exercise of a global development and commercialization license with Rani Therapeutics, building on an agreement that included a licensing and supply deal aimed at developing oral ustekinumab in January of last year... Full

Amgen Taking Different Path to Weight Loss Windfall

(2/6, Deena Beasley, Reuters) ...The popularity of a new generation of weight-loss medicines is inspiring a growing number of drugmakers to pursue paths emulating Eli Lilly's highly-effective Zepbound, but Amgen is taking a unique approach...With its current products and others in development, including cancer and rare disease drugs, Amgen is looking at "solid mid-single-digit growth, although clearly an obesity win could move this into double-digit growth territory," Morningstar analyst Karen Anderson said. A weight-loss drug launch from Amgen would not happen before 2026, she said... Full

Takeda, Azurity Settle Patent Suits On Rival Hypertension Drugs

(2/6, Christopher Yasiejko, Bloomberg Law) ...Takeda Pharmaceutical Co. and Azurity Pharmaceuticals Inc. settled patent-infringement lawsuits over generic versions of two hypertension drugs, resolving their cases over a Turkish company's proposed copy of Edarbi and Alkem Laboratories Ltd.'s proposed generic Edarbyclor, mooting this week's joint bench trial... Sub. Req'd

Federal Judge Tosses Out Antitrust Lawsuit Against Eli Lilly, Sanofi Over Diabetes Drug Discounts

(2/5, Katherine Lewin, Endpoints News) ...A federal judge in New York dismissed an antitrust lawsuit against drugmakers alleging that they conspired to boost profits by limiting discounts on insulin beginning in 2020...They alleged that Sanofi-Aventis, Eli Lilly, Novo Nordisk and AstraZeneca broke state and federal laws by "suddenly, and in coordination with one another," agreeing to limit drug discounts through the federal 340B program, which allows safety-net hospitals and clinics to buy drugs like insulin at cheaper prices... Full

Pharma Sees Opening For PBM Reforms, IRA Tweaks, 340B Revamp This Year

(2/5, Jessica Karins, InsideHealthPolicy) ...Lobbyists on pharmaceutical and biological products are narrowing in on a few topics they think they could get through Congress this year, chiefly pharmacy benefit manager reforms, tweaks to the Medicare drug price negotiation program and overhaul of the 340B program. They have no shortage of issues they hope lawmakers will address in the coming months, but worry conflicts in Congress over its drawn-out appropriations process and the presidential election could prevent action on a broader agenda... Sub. Req'd

Bill Gives Small-Molecule Drugs More Time On Market Before Negotiation

(2/5, Gabrielle Wanneh, InsideHealthPolicy) ...House Energy & Commerce health subcommittee chair Brett Guthrie (R-KY) wants to address what he believes is unfair treatment of small-molecule drugs under the Inflation Reduction Act through new bipartisan legislation introduced Friday (Feb. 2) that would extend how long small-molecule drugs have following entry into the market before CMS can consider them eligible to be selected for drug price negotiation... Sub. Req'd

The Lone Democrat Willing to Weaken Medicare's Power to Negotiate Drug Prices

(2/5, Rachel Cohrs, STAT Plus) ...Two Republican lawmakers who introduced legislation to water down the Inflation Reduction Act's Medicare drug price negotiation program managed to find themselves a Democratic co-sponsor — even though every single Democrat in Congress in 2022 voted for the legislation. They found their perfect candidate in Rep. Don Davis, a Democrat representing a North Carolina district that includes parts of the state's Research Triangle...The new legislation is the pharmaceutical industry's biggest ask — it would extend drugmakers' period of immunity from negotiation from nine years to 13 years, to bring it in line with the immunity period for biologics... Sub. Req'd

Medicare Now Negotiating Price of Drug That Costs $7,100 in US Vs. $900 in Canada

(2/6, Tami Luhby, CNN) ...Sen. Bernie Sanders is once again taking the pharmaceutical industry to task, issuing a report Tuesday that highlights the cost of three blockbuster drugs that are far pricier in the US than in other countries. The differences are striking. The annual list price of Bristol Myers Squibb's Eliquis, a blood thinner that reduces the risk of stroke, is $7,100 in the US. But in Japan, it's $940; in Canada, it's $900; in Germany, it's $770; in the United Kingdom, it's $760; and in France, it's $650... Full

A Johnson & Johnson Worker Alleges Company Overpaid for Drugs

(2/5, John Tozzi and Chris Dolmetsch, Bloomberg) ...The complaint alleges that J&J mismanaged the company's prescription-drug benefits program, costing federally regulated plans and J&J workers millions of dollars due to higher payments for drugs, increased premiums, deductibles, copays and lower wages or limited growth... Full

Big Pharma Still Needs Trial Success to Overcome Looming Patent Panic

(2/6, Financial Times) ...Risks from patent expiries have been relatively low since 2020. But the percentage of prescription drug sales at patent risk industry-wide in 2027-2028 will reach the highest level since 2015, reckons Evaluate. In theory, it should be slightly different this time — compared with the patent panics of the past. The move towards harder-to-copy biologic drugs means drugmakers do not face such a steep drop-off in sales after exclusivity expires. Companies have become more adept at protecting key drugs, both through litigation and by seeking approvals in new diseases... Full

Much Ado About Nothing: Why 'March-In' Rights Won't Lower Drug Prices

(2/5, Alfred B. Engelberg, Health Affairs) ...The bottom line is that the Administration's proposal on march-in rights is a waste of time and resources. Most important drugs will be subject to Medicare price reductions before there is any possibility that a lower cost drug is approved because march-in rights were exercised by the government. Rather than making a feeble effort to belatedly lower the unreasonable prices of federally funded drug discoveries, and the Administration should focus its efforts on preventing such prices from ever being charged... Full

How Your Prescriptions Can Lower Health Care Spending

(2/6, Steve Ubl, RealClearHealth) ...There is a pervasive belief in Washington, D.C. that the only way to generate savings in a complex health system is with more complexity. But that's a cruel myth that, too often, leads to higher costs. There is a better way, a proven strategy that is already curbing costs: access and use of prescription medicines... Full

Are We Valuing Prescription Drugs Appropriately?

(2/5, Peter J. Neumann and Joshua T. Cohen, Health Affairs) ...With some new drug therapies priced like high-end condos, the question of whether prescription drugs are undervalued may seem misplaced...We argue that methods for valuing drug therapies need updating. Such improvements would make the estimated value of some, although not all, prescription drugs more favorable in economic assessments. In the long run, these improvements will have the effect of promoting the continued development of drugs that produce health benefits that are worth more than what society must spend to invent those drugs in the first place... Full

How Firms Are Using ICH Q12 Guideline To Reduce US FDA Oversight Of Manufacturing Changes

(2/5, Bowman Cox, Pink Sheet) ...Most pharmaceutical companies that have incorporated features from the International Conference on Harmonisation's Q12 lifecycle management guideline into their applications to the US Food and Drug Administration for new drug approval or biologics licensing have won reduced oversight of future manufacturing changes. For example, Sandoz International GmbH recently used ICH Q12 tools to win reduced oversight of potential changes, regulatory CMC director Thomas Stangler told the CASSS WCBP conference in Washington, DC, in January... Sub. Req'd

Could Virtual Tools Help US FDA Eliminate Inspection Backlog?

(2/5, Derrick Gingery, Pink Sheet) ...A former CDER compliance office director suggested the agency initiate virtual visits at low-risk facilities to help catch up on manufacturing facility surveillance inspections. Increasing virtual inspections may help the US Food and Drug Administration reduce its surveillance inspection backlog, but public health needs could complicate such a plan... Sub. Req'd

FDA Gives Drugmakers 3 Weeks to Begin Reporting Supply Chain Data

(2/5, Ferdous Al-Faruque, Regulatory Focus) ...The US Food and Drug Administration (FDA) is giving drugmakers and others who are involved in the drug manufacturing process three weeks to comply with new reporting requirements intended to help address potential drug shortages...FDA notes that establishments that manufacture drugs in the US must register with the agency. The same applies to foreign establishments that are engaged in making drugs that are then imported into the US... Full

States Use New Authority to Assert Home Turf in Antitrust Cases

(2/5, Danielle Kaye, Bloomberg Law) ...The US Judicial Panel on Multidistrict Litigation last week denied an attempt by top drugmakers to group the cases into multidistrict litigation in Pennsylvania, citing a year-old law that grants state attorneys general more say in where their antitrust cases are heard...Drug companies Teva Pharmaceutical Industries Ltd., Sandoz Group AG, and Aurobindo Pharma Ltd.—three of the defendants—argued in a November filing that transferring the case out of Pennsylvania would "throw this MDL into chaos and require Defendants to litigate the same allegations and legal claims in multiple fora." The drugmakers are simultaneously facing several class action lawsuits over allegations of price-fixing... Full

Pharma Group Demands Pause On Illinois Anti-Price Gouging Law

(2/5, Celine Castronuovo, Bloomberg Law) ...The US trade group representing the generic drug and biosimilar industry wants a federal judge to put a hold on an Illinois law aimed at curbing price hikes, citing the industry's past wins in challenging state drug pricing laws...AAM also argued the group will "suffer significant economic losses they will not be able to recoup" if US District Judge Virginia M. Kendall doesn't order Illinois officials to stop enforcing the law, which AAM first targeted in its lawsuit filed Jan. 22... Sub. Req'd

The State Capped the Cost of EpiPens, But Patients Are Having a Hard Time Getting the Right Price

(2/5, Steve Staeger, 9 News) ...Pharmacists tell 9NEWS the law or the agency overseeing it never established a protocol for seeking reimbursement from a manufacturer. Emily Zadvorny, CEO of the Colorado Pharmacists Society, said pharmacists are often paying hundreds of dollars for a single two-pack injector kit to sit on their shelves...Teva Pharmaceuticals, the manufacturer of the brand name Epi-Pen, sued the state last fall, calling the law requiring them to reimburse pharmacists for a cost-capping measure unconstitutional. A federal judge denied a motion for an injunction that would have stopped the law. Steve On Your Side reached out to the company for a comment on this story, but a spokesperson has yet to respond to the request... Full

EMA Mulls Dropping Comparative Efficacy Trials For Biosimilars

(2/6, David Wallace, Generics Bulletin) ...In a move that could hold major promise for the biosimilars industry, the European Medicines Agency has opened up a consultation on re-evaluating the need for comparative efficacy studies to support biosimilar applications...Speaking to Generics Bulletin in a recent interview, Medicines for Europe director general Adrian van den Hoven said that moves to eliminate the need for confirmatory efficacy trials were "based on the science; the scientific evidence is clearly there that we can go in this direction." This was "really, really important," he said, because "around 50% of the biologics going off-patent and losing exclusivity do not have a biosimilar targeting them."... Global Sub. Full

EU ‘Pathfinder' Project Aims To Improve Cancer Drug Development & Assessment

(2/5, Ian Schofield, Pink Sheet) ...The European Medicines Agency is planning a series of workshops and other events with stakeholders in the first half of this year to discuss ways of improving the way new cancer drugs are developed and evaluated in the EU...The workshop will be "an important one because it will for the first time present publicly what this group has done," the agency's head of oncology, Francesco Pignatti, told the Pink Sheet. "It will look at what academic studies can do in terms of treatment optimization and what regulators can try to do to support this." The workshop "will be multistakeholder. So industry will be in the meeting."... Sub. Req'd

Creating A ‘Critical Mass': Outgoing EURORDIS Chief On 25 Years Of EU Orphan Disease Policy

(2/5, Eliza Slawther, Pink Sheet) ...As Yann Le Cam prepares to step down from his role as leader of the EU network of rare disease patient organizations, EURORDIS, he reflects on the organization's role in almost three decades of major changes to Europe's orphan disease and drug policy. The EU's orphan drug and rare disease landscape has undergone significant changes over the last 25 years, many of which have been influenced by EURORDIS-Rare Diseases Europe, according to its chief executive, Yann Le Cam... Sub. Req'd

Critical Medicines Alliance Gains Momentum Under Belgian Presidency

(2/5, Nicole Verbeeck, Euractiv) ...Critical medicines are rapidly disappearing from European markets, Belgian Health Minister, Frank Vandenbroucke, told the European Parliament's Environment Committee, emphasising the need for urgent action...Hugues Malonne, CEO of the Belgian Federal Agency for Medicines and Healthcare Products underlined the persistent shortage of medicines as a critical bottleneck. "In Belgium alone, 757 packages are currently unavailable or only available in limited quantities, reflecting a situation mirrored to varying degrees across EU countries, as indicated by the EMA shortages catalogue", he told Euractiv... Full

NPPA Notifies Retail Prices of 39 New Drug Formulations, Special Prices for Seven Formulations

(2/6, Pharmabiz.com) ...The National Pharmaceutical Pricing Authority has notified the retail price of 39 new drug formulations, including anti-diabetic combinations, antibiotics and painkillers, among others. The Authority has also extended the special ceiling prices for seven formulations of Promea Therapeutics Pvt Ltd, based on the special features of their packaging... Full

India's Interim Budget Pushes Innovation, Green Production, HPV Vaccination

(2/6, Vibha Ravi, Pink Sheet) ...India's interim budget 2024 hikes allocation for production-linked incentive schemes in pharmaceuticals, supports biotech start-ups - particularly green ones- and sets the right note for inclusion of HPV vaccination in the country's Universal Immunization Program, one of the world's largest public health programs...India's interim budget 2024 furthers the government's push for self-reliance with a hike in the allocation for production-linked incentive (PLI) schemes related to pharmaceuticals, support for green bio-production processes and innovation, as well as growth of medical colleges... Sub. Req'd

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