Monday, August 31, 2026

 

 

Alvotech Announces FDA Acceptance for Review of Biologics License Application for AVT80, Expanding Proposed Biosimilar

(8/31, Alvotech) ...Under a partnership with Teva Pharmaceutical Industries Ltd. Alvotech is responsible for the development and manufacturing of AVT80, while Teva is responsible for commercialization... Full

 

BioXcel Files for Bankruptcy, Will Sell Assets to Teva for Up to $125M

(8/28, Michael Gibney, BioSpace) ...AI neuroscience biotech BioXcel Therapeutics has filed for bankruptcy and plans to sell all of its assets to Tel Aviv-based pharma giant Teva Pharmaceuticals... Full

 

Teva Saddles Up as Stalking Horse Bidder for Bankrupt BioXcel's Neuroscience Portfolio

(8/28, Nick Paul Taylor, Fierce Biotech) ...The bankruptcy paperwork revealed that, after months of efforts to land a deal, Teva emerged (PDF) as the most viable strategic bidder for the assets. With Teva having already done extensive due diligence of the assets, BioXcel selected the company as the stalking horse bidder for the bankruptcy process... Full

 

Teva Bids Up to $125M for BioXcel Neuro Assets in Bankruptcy Sale

(8/28, Anna Bratulic, FirstWord PHARMA) ..."This opportunity strengthens our neuroscience portfolio and reflects our disciplined approach to pursuing innovative assets with a clear strategic fit…while balancing risk and value creation," said Evan Lippman, EVP of business development at Teva, in a company release... Full

 

Teva Pharmaceuticals to Acquire BioXcel Assets for up to $125m

(8/31, Salong Debbarma, Pharmaceutical Technology) ...Should Teva not prevail as the successful bidder, the company would receive a break-up fee and reimbursement of certain expenses, as outlined in the agreement... Full

 

 

Trump Is Writing a Most Favored Nation Clause That Nobody Signed

(8/28, Marc L. Busch, Barry Appleton, The Hill) ...If Washington wants the best treatment Canada later gives another country, there is a straightforward solution: negotiate for it. What Washington should not do is obtain through unilateral tariff statutes what it failed to obtain at the negotiating table... Full

 

EXCLUSIVE: How PBM Reform and TrumpRx Delivered a Historic Affordability Win for Republicans

(8/28, Ava Nicholson, Washington Reporter) ...The Washington Reporter has documented the growing Republican support for TrumpRx for months...There is also evidence that lower prices have come at the same time as increased investment in the sector. Major pharmaceutical companies are simultaneously making enormous investments in American manufacturing and research while prices are declining... Full

 

The Hidden Costs Behind Your Prescription Drugs

(8/30, David Martin Davies, Texas Public Radio) ...Antonio Ciaccia, CEO of nonprofit 46brooklyn Research, argues that the system rewards negotiating discounts from inflated prices rather than competing to offer the lowest price upfront. Ciaccia describes situations in which "the sick patient overpays for a drug and a rebate is generated that doesn't go to the patient." Instead, that money can flow to pharmacy benefit managers, insurers or employers... Full

 

US FDA Scraps Program That Paid Bonuses For Completing Speedy Drug Reviews

(8/28, Maaisha Osman, Derrick Gingery, Pink Sheet) ...The US Food and Drug Administration is scrapping a controversial program that offered bonus payments to drug reviewers who completed their work ahead of schedule, according to an internal email shared with the Pink Sheet. Center for Drug Evaluation and Research Acting Director Michael Davis announced the decision on Aug. 24. "After assessing the pilot of this program and gathering feedback from reviewers, we have determined not to permanently operationalize it in its current form," Davis wrote in the email... Global Sub. Full

 

America's Drug Shortage Is a National Security Crisis

(8/28, Joseph Varon, MD, Brownstone Institute) ...A rational national strategy would identify medications whose absence could rapidly threaten life or cripple hospital operations, determine where their active ingredients and critical starting materials originate, identify products dependent upon one manufacturer or one geographic area, and create incentives for redundant production. For truly essential medicines, redundancy should not be regarded as waste. It should be regarded as insurance... Full

 

Florida AG Sues Prime Therapeutics, Express Scripts for Alleged Price-Fixing

(8/28, Paige Minemyer, Fierce Healthcare) ...Florida Attorney General James Uthmeier is suing Express Scripts and Prime Therapeutics, alleging that a partnership between the two pharmacy benefit managers allows them to illegally fix prices. Express Scripts and Prime entered into a partnership in 2019, through which Express Scripts would provide Prime with certain services related to retail pharmacy networks and contracting with drugmakers. In the lawsuit, Uthmeier's office argues that the collaboration has led Prime to adopt far lower pharmacy reimbursement rates... Full

 

How the Terminal Disclaimer Went From Limiting Monopolies to Blocking Generics

(8/28, Wayne T. Brough, R Street) ...This piece provides a more detailed examination of terminal disclaimers and their role in strategic patenting. Understanding the evolution and use of terminal disclaimers also underscores the importance of legislative reforms, such as the Eliminating Thickets to Increase Competition (ETHIC) Act, that aim to restore drug market competition... Full

 

 

Alteogen Wins First Sales Milestone as Keytruda SC Revenue Surges

(8/31, Park Su-Hyeon, Chosun Biz) ...Alteogen disclosed on the 31st that it is set to receive a $25 million milestone (about 34.4 billion won) from MSD tied to sales of Keytruda SC (brand name Keytruda Qlex) (Keytruda Qlex)...For Alteogen, this milestone is meaningful in that it signals the start of securing revenue linked to actual product sales, beyond royalties incurred during development stages such as clinical trials and approvals... Full

 

 

Aurobindo's Arm, Lannett Company, Launches Generic Version of Advair Diskus in US

(8/31, The Hindu BusinessLine) ..."This launch marks the first product from our inhalation pipeline to be commercialised in the US, reflecting our continued focus on expanding our portfolio of complex and differentiated inhalation products,'' Hyderabad-based Aurobindo Pharma said in a release on Monday... Full

 

Formosa Pharma Files European Trial Application for Kadcyla Biosimilar TSY-110

(8/31, BioSpectrum Asia) ...Formosa Pharmaceuticals has submitted a Clinical Trial Application to European regulators for a pivotal study of TSY-110, its biosimilar candidate referencing the HER2-targeting antibody-drug conjugate ado-trastuzumab emtansine... Full

 

Natalizumab Biosimilar Shows Limited Cost-Effectiveness in MS

(8/28, Pearl Steinzor, The Center for Biosimilars) ...Overall, the assessment found no direct clinical evidence establishing the comparative effectiveness of natalizumab or its biosimilar specifically in HARRMS. Although natalizumab had lower modeled costs and higher QALYs than ocrelizumab, most other comparators had greater net benefit at willingness-to-pay thresholds of approximately $27,000 to $41,000 per QALY... Full

 

 

Eli Lilly to buy Merida Biosciences in $2.88 billion deal

(8/31, Reuters) ...Eli Lilly said on Monday it would acquire privately held Merida Biosciences for up to $2.88 billion in cash, expanding its efforts to develop treatments for immunity-related and allergic diseases... Full

 

A $480,000-a-Year Pill Reflects a New Normal for Cancer Drugs

(8/31, Rebecca Robbins, The New York Times) ..."We allow pharmaceutical companies to charge whatever they want, and without any clear rationale, other than how much they think they can get," said Dr. Aaron Kesselheim, a professor of medicine at Harvard and Brigham and Women's Hospital who studies drug pricing. A drug's sticker price is not the real price paid by patients or their insurers - it's just the starting point for negotiations that lower the final price for the employer or the government. But while that dynamic sharply reduces the true prices of diabetes and autoimmune drugs, the final price for cancer drugs is typically only slightly lower than the sticker price... Sub. Req'd

 

Pharma Industry Stares Down Biggest Patent Cliff in Decades

(8/28, The Wall Street Journal) ...The scale of the cliff "is what has driven, and will continue to drive, companies to seek out new growth opportunities," said Greg Graves, a senior partner in the life sciences division of McKinsey. In all, more than $500 billion of projected global sales are at risk of losing patent protection by 2033, according to biopharma market-research company Norstella. The patent cliff has driven a wave of acquisitions as drugmakers race to replace expiring revenue before it vanishes. Dealmaking is at its highest level in seven years... Sub. Req'd

 

Pharma Stocks Soar as Investors Seek AI Alternatives

(8/31, Financial Times) ...Drugmakers are expected to receive a further boost on Monday, when Bayer, Takeda, CSL and several mid-size biotechs are expected to announce new pricing deals with the White House, according to two people familiar with the matter... Sub. Req'd

 

AI Turns to Health Care for an Image Fix

(8/31, Adriel Bettelheim, Axios) ...Breakthroughs may still be years away. That's hardly reassuring to an increasingly anxious U.S. public that's gone NIMBY against data centers, with moratoriums, threatened lawsuits and fears of AI models taking more jobs... Full

 

Boston Scientific Says Cyberattack Has Disrupted Product Manufacturing

(8/28, Ricky Zipp, MedTech DIVE) ..."We are directing resources toward the systems that have the greatest impact on customers and product delivery and have engaged external experts to assist in the restoration and recovery efforts," the company said in the statement. "Progress is being made in recovering our core business system and we will provide further updates as functionality is restored."..."Once systems are restored and pairing with home monitoring equipment occurs, the device will transmit recorded data to the remote monitoring system," Boston Scientific said. "Timeline for full restoration is not yet known."... Full

 

Cipla Pharma License Cancellation: FDA Withdraws Order After Bombay HC Raps it for Going 'Overboard'

(8/29, PTI) ...The Maharashtra FDA on Saturday withdrew its order to cancel the drug sale licence of Cipla Pharma & Life Sciences's Carry and Forwarding unit in Pune after the Bombay High Court pulled up the regulator for going "overboard" and behaving in a "high-handed" manner... Full

 

US FDA Classifies Cipla Subsidiary's New York Facility Inspection as 'Voluntary Action Indicated'

(8/29, Asmi Saxena, CNBC TV18) ...The US FDA inspected Unit 3 of InvaGen Pharmaceuticals at Central Islip in Long Island, New York, from July 13 to July 17, 2026. Cipla disclosed the classification in a regulatory filing dated August 28... Full

 

 

Modi Is Hedging Against Trump, One Deal at a Time

(8/29, Anupreeta Das, The New York Times) ...Many of the pacts underscore India's need for support to create manufacturing jobs and technology to drive its growth, analysts said. But India is also working with countries to build infrastructure and find new buyers for its pharmaceuticals, as the world's biggest maker of generic drugs. Unlike the diffuse nature of many previous meetings with leaders, the recent partnerships are far more focused, outlining specific goals, targets and numbers... Sub. Req'd

 

Africa, Latin America & Eastern Europe Markets to Play Big Role in India's Next Phase of Export Growth: Expert

(8/31, Shardul Nautiyal, Pharmabiz.com) ...Emerging markets across Africa, Latin America and Eastern Europe are expected to play a big role in India's next phase of pharma export growth by reducing dependence on traditional markets and creating new opportunities for demand, says Joydeep Ghosh - partner at Deloitte Life Science and Healthcare Lead for South Asia. He further adds that rising healthcare needs, limited local manufacturing capacity, and growing demand for affordable, high-quality medicines are making these regions increasingly attractive for Indian companies... Full

 

China Shows Way in New Pharma Race: Own Meds, Don't Just Make 'Em

(8/31, Naina Sharma, Asia Times) ...The common thread is the capacity to turn molecules, clinical evidence and biological data into intellectual property, regulatory approvals and licensable drug assets. For India, and for African economies trying to build pharmaceutical industries, that distinction matters. China's recent trajectory suggests that manufacturing is no longer the only route to pharmaceutical power... Full

 

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