Friday, August 28, 2026

 

 

Teva Bids $57.5M for BioXcel Agitation Drug in Bankruptcy Sale

(8/28, StreetInsider.com) ...Teva Pharmaceutical Industries Ltd. has placed a stalking horse bid to acquire certain assets from BioXcel Therapeutics, Inc., including a dexmedetomidine sublingual film product, through a court-supervised bankruptcy auction process, according to a company statement...The asset, known as BXCL501, is a dexmedetomidine sublingual film currently under FDA review for at-home use in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The FDA has set a Prescription Drug User Fee Act target action date of Nov. 14, 2026... Sub. Req'd

 

Teva Unit Bids to Acquire Neuroscience Product from BioXcel Therapeutics

(8/28, The Fly) ...Under the terms of the Agreement, Teva would acquire worldwide rights to the assets including dexmedetomidine sublingual film for an upfront payment of $57.5M and up to an additional $67.5M in contingent payments. These include a range of time-based payments linked to the timing of the pending FDA approval, including potential delays in approval, as well as payments tied to the achievement of specified sales milestones... Sub. Req'd

 

BioXcel Therapeutics Enters Asset Sale Agreement with Teva

(8/28, The Fly) ...BioXcel Therapeutics announced that it has entered into an asset sale agreement with Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries, for substantially all of the company's assets. This includes IGALMI sublingual film and the related pending supplemental New Drug Application of BXCL501 for potential at-home use for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Concurrent with the execution of the asset sale agreement, BioXcel Therapeutics and its subsidiaries, OnkosXcel Therapeutics, LLC and OnkosXcel Employee Holdings, LLC, have commenced voluntary Chapter 11 proceedings in the US... Sub. Req'd

 

 

Apotex Addresses Tariffs As US-Canada Tensions Rise

(8/28, Dave Wallace, Generics Bulletin) ..."We remain engaged directly and through industry associations with the US administration," [CEO Jeff Watson] said, "on how our footprint can be leveraged to benefit a North American onshoring initiative that we share with both the US and Canadian governments."..."We certainly understand the objectives of the US administration, which really don't differ that much from the Canadian domestic policy on really building a sovereign domestic supply chain that that can be counted on," Watson elaborated. "So we have been engaged, certainly with the administration and with the associations."... Global Sub. Full

 

Could USTR German Pricing Investigation Lead To Policy Misfire And Damaged Trading Relations?

(8/27, Francesca Bruce, Pink Sheet) ...The TACD, which represents EU and US consumer rights, public health, intellectual property rights, and trade policy experts, said it opposes tariff threats made by the current US administration "to coerce its trading partners into raising medicine prices." It warned that higher prices abroad "will not lower prices for US patients but will instead further boost pharmaceutical industry profits and undermine policies that keep medicine prices in check." The TACD said the concerns were similar to those it raised earlier in the year about the US most favored nation policy... Global Sub. Full

 

Right Goal, Wrong Strategy: Why Trump's 'Made in America' Plan Leaves Us Vulnerable

(8/27, David Adler, Washington Examiner) ...Domestic production should remain the preferred option, particularly for medicines essential to public health and national security. But where complete domestic production is not yet practical, imports should not all be treated alike. A medicine supported by several qualified suppliers, geographically separated manufacturing sites, and reliable production in allied countries presents a different risk from one dependent on a single vulnerable source. The administration should make supply-chain resilience part of the tariff framework... Full

 

Health Brief: Pharma's Legal Plan B

(8/27, Megan R. Wilson, The Washington Post) ...Last week, Teva Pharmaceuticals scored a partial legal victory in one of its niche challenges to provisions in the Inflation Reduction Act. A federal appeals court in Washington, D.C., preserved a key piece of the Medicare drug-negotiation framework by saying that CMS was simply abiding by the law's requirements when it lumped two versions of the same drug together for the purposes of negotiation. However, it gave Teva an opening on a separate issue: whether CMS can require a generic version of a drug to be meaningfully on the market before it can be used to keep the brand-name version out of Medicare negotiations — taking aim at the so-called "bona fide marketing" standard. The court sent that question back to the district court... Full

 

FDA Review Details Use of Manufacturing Process Models in Drug Applications

(8/27, Joanne S. Eglovitch, Regulatory Focus) ...According to the review, 12 of these submissions were approved before their goal date by an average of 20.3 days early; the three submissions that were not approved by their target date faced issues unrelated to modeling. The authors also noted that prior research has shown that submissions that feature continuous manufacturing have been approved faster than those relying on traditional batch manufacturing... Full

 

Haystack Project: FDA, CMS Statute Changes Needed Before Drug Repurposing

(8/27, Lauren Brensel, Inside Health Policy) ...Haystack told Inside Health Policy a bill awaiting discussion in the Senate Finance Committee, plus legislative change to amend FDA standards for drug research, would help make drug repurposing effective for rare disease patients, aligning with the goals of HHS Secretary Robert F. Kennedy Jr.'s "Make America Healthy Again" movement... Sub. Req'd

 

Appeals Court Says Arkansas Can Enforce Dispensing Fee Rule on PBMs

(8/27, Andrew Demillo, Arkansas Advocate) ...Federal law doesn't prevent Arkansas from enforcing a rule requiring pharmacy benefit managers to include dispensing fees in their reimbursements to pharmacies for prescription drugs, an appeals court has ruled. A three-judge panel of the 7th U.S. Circuit Court of Appeals on Wednesday upheld a federal judge's dismissal of the lawsuit challenging the 2024 rule adopted by Arkansas imposing new requirements on pharmacy benefit managers, also known as PBMs... Full

 

James Uthmeier Files Lawsuit Against 2 Pharmacy Benefit Managers Amid Allegations of Price Fixing

(8/27, Drew Dixon, Florida Politics) ...Attorney General James Uthmeier is launching a lawsuit against Pharmacy Benefit Manager (PBM) companies Prime Therapeutics and Express Scripts. Uthmeier announced the legal action as he accused the companies of price fixing through agreements he claims threaten affordable access to medication for Floridians. The lawsuit states the companies engaged in "collaboration" to significantly lower rates of reimbursements to pharmacies fulfilling prescriptions that use the firms, impacting prices paid by Floridians needing medication... Full

 

The First Point of Access Isn't a Pharmacy. It's Affordability

(8/27, Dr. Johnny Garcia, Heather Cascone, New Jersey Globe) ...Somewhere along the way we've started treating access to medicine as though it's only about where a patient fills a prescription: an independent pharmacy, a chain pharmacy, or mail order pharmacies. But the first point of access isn't a pharmacy; it's affordability. We can debate which pharmacy should fill a prescription all day long. But if the prescription is unaffordable, that debate is academic... Full

 

Texas Senate Hopeful Talarico Teams With Mark Cuban on Plan to Break Up Healthcare 'Monopolies'

(8/27, Justin Papp, CNBC) ...Texas Democratic Senate candidate James Talarico is out with a new plan, first shared with CNBC, to break up what he says are healthcare monopolies and bring down the cost of prescription drugs. And he's teaming up with entrepreneur Mark Cuban to launch it... Full

 

 

Zambon Announces European Commission Approval of Hopledo® for Adults with Parkinson's Disease and Moderate to Severe Motor

(8/28, Zambon) ...Zambon today announced that the European Commission (EC) has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson's disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026... Full

 

As RevMed Preps for 'Historic' Pancreatic Cancer Launch, Questions Linger on the Ground

(8/27, Darren Incorvaia, Fierce Pharma) ...Analysts have long touted daraxonrasib's blockbuster potential; analysts from Evercore ISI expect 2027 sales to already hit $1.76 billion, according to an Aug. 26 note, while Guggenheim Securities expects sales of around $900 million next year that then skyrocket to $2.2 billion in 2028. "We continue to expect a potentially historic oncology launch," the Evercore analysts wrote. "Rasonque has the ingredients to be one of the fastest oncology launches in history, if not the fastest."... Full

 

China Approves J&J Psoriasis Pill Icotyde, Says Drugmaker

(8/27, Reuters) ...It was approved in China for moderate-to-severe plaque psoriasis, J&J said in a statement. Asked about availability, pricing and sales expectations for the local market, a spokesperson referred Reuters to the statement... Full

 

 

Norwich Optimistic After Appeals Court Opens Door For Xifaxan Reversal

(8/27, Dave Wallace, Generics Bulletin) ...Central to the appeals court's latest decision was an argument from Norwich that Teva's version had not obtained timely tentative approval, meaning that Teva had forfeited its first-applicant exclusivity. The appeals court found in Norwich's favor, concluding that the FDA had not applied the correct "but-for" causation standard to Teva's application... Global Sub. Full

 

Mylan, Lannett Must Face Humana Jury On Generic Price-Fixing Claims

(8/28, Dean Rudge, Generics Bulletin) ...In an August 26 opinion, District Judge Cynthia Rufe denied in full Mylan's and Lannett's individual summary judgment motions; rejected a joint bid for summary judgment on Humana's overarching conspiracy claim; and also denied Lannett's separate motion to dismiss... Global Sub. Full

 

Adalvo Announces Generic Brivaracetam Launch Across Europe

(8/27, Anabel Costa-Ferreira, Generics Bulletin) ...After being first to market earlier this year in Croatia, Maltese-based company Adalvo is now pouncing on a patent expiry to deliver a day-one launch of generic brivaracetam tablets across European markets... Global Sub. Full

 

Takeda Patent Suit Puts Early Entyvio Biosimilar Launches Under Pressure

(8/28, Dean Rudge, Generics Bulletin) ...Polpharma must defend itself against accusations of infringing half-a-dozen US patents covering Entyvio (vedolizumab), after originator Takeda sued the biosimilar developer in a dispute that could shape how early intravenous vedolizumab competition reaches the US market... Global Sub. Full

 

Apotex Launches Help Offset Lenalidomide Slide And Ophthalmic Pause

(8/27, Dave Wallace, Generics Bulletin) ...On a geographical basis, sales in Canada increased by around 11% to CAD413m - partly due to the semaglutide launch - while US turnover excluding lenalidomide fell by almost a tenth, or CAD34m, amid the ophthalmic pause. And international turnover was up by around 8% to CAD72m, backed by growth in Latin America but offset by a decline in the Middle East "driven by ongoing political conflicts and lower sales of certain products in this region... Global Sub. Full

 

Cancer Biosimilars Associated With Lower Costs for Insurers and Patients, UCLA Study Finds

(8/27, Denise Heady, MA, UCLA Health) ...The findings, published in JAMA Oncology, show that patients with cancer who exclusively used biosimilars had average monthly costs that were $3,820 lower for insurers and $39.50 lower out of pocket compared with patients who exclusively used the original branded biologic drugs. The results provide evidence that market competition enabled by entry of biosimilars may help reduce the cost of cancer biologic drugs... Full

 

 

Genentech Doubles down on ADC-Resistant Cancers with $1B DualityBio Pact

(8/28, Nick Paul Taylor, Fierce Biotech) ...Approved ADCs such as AstraZeneca and Daiichi Sankyo's Enhertu and Gilead's Trodelvy deliver cytotoxic topoisomerase inhibitors to cells that express certain receptors. As the ADCs move into earlier lines of therapy—Enhertu and Trodelvy are both approved for first-line use—an unmet need is emerging among patients who progress on the treatments and are less responsive to topoisomerase inhibitors... Full

 

Lupin Targets Bigger Global Role For Europe And Emerging Markets

(8/28, Dean Rudge, Generics Bulletin) ...In an exclusive interview, Thierry Volle, Lupin's president for Europe, the Middle East and Africa region and emerging markets, told Generics Bulletin that while the US and India would remain the company's dominant businesses, the regions under his control were assuming greater importance as Lupin sought to build a genuinely global organization... Global Sub. Full

 

New Data Could Widen Use of AstraZeneca, Amgen Immune Disease Drug

(8/27, Delilah Alvarado, BioPharma DIVE) ...The two companies said Thursday their drug, which is already approved for severe asthma and chronic rhinosinusitis, met all of its objectives in a Phase 3 study in eosinophilic esophagitis. They didn't provide details, but said that treatment was associated with "statistically significant and clinically meaningful improvements" across all main and secondary study goals... Full

 

BMS Splashes Out $173M to Build 2nd Radiopharmaceutical Plant in Indiana

(8/27, Kevin Dunleavy, Fierce Pharma) ...Construction will begin this year on the 225,000-square-foot plant, which will be situated in the Anson Industrial Park, according to a Thursday release from Indiana Governor Mike Braun. The new campus will complement the Bristol subsidiary's existing 77,000-square-foot radiopharmaceutical manufacturing facility 20 miles to the southwest in Indianapolis... Full

 

Why the Drugmaker Behind a Pancreatic Cancer Breakthrough Stayed Independent

(8/27, Xavier Martinez, The Wall Street Journal) ...RevMed is set on doing this on its own. In a matter of months, it has built its first-ever sales force, distribution network and reimbursement operation from scratch. It has struck deals to make the drug overseas and is planning to invest in several manufacturing lines to guard against bottlenecks... Sub. Req'd

 

 

British PM Reportedly Ready to Announce Israeli Settlement Trade Ban in Coming Weeks

(8/27, Mathilda Heller, The Jerusalem Post) ...According to both reports, citing government officials, Burnham is considering a trade embargo within the coming weeks. The new sanctions regime would likely stop the exchange of both goods and services... Full

 

 

EU Flags Shortage of Schizophrenia Drug Injections Due to Manufacturing Issues

(8/27, Reuters) ...The European Medicines Agency on Thursday disclosed a shortage of an injectable medicine used to treat schizophrenia in some member EU states due to issues at contract manufacturer Pharmathen International...The shortage affects medicines marketed by Advanz Pharma, Adamed Pharma, Alter, Belupo, Biogaran, EGIS Pharmaceuticals, Elpen, G.L. Pharma and Innovis Pharma, the EMA said... Full

 

India's Pharma Ambition Shifts From Manufacturing Powerhouse To Global R&D Hub

(8/27, Fatema Khatun, BW Healthcare) ...India's pharmaceutical industry is entering a phase where its established strength in cost-efficient manufacturing could become the foundation for a larger ambition: becoming a global hub for biopharma innovation, research and development. Industry experts say the country has the manufacturing base, scientific talent and market scale needed for the transition, but significant investment in infrastructure, early-stage research and specialised skills will be required... Full

 

MFDS to Deploy AI Reviewer for Drug Approvals as Early as October

(8/28, Kwon Min-seon, Korea Biomedical Review) ...The Ministry of Food and Drug Safety (MFDS) plans to invest 22.3 billion won ($16.2 million) over the next three years to develop an "AI reviewer" to assist staff with drug approval reviews. The system will be based on EXAONE, an AI model developed by LG AI Research, and could be deployed for generic drug reviews as early as October... Full

 

Korea Delays Generic Drug Price Cuts to April Next Year

(8/28, Park Ji-soo, Seoul Economic Daily) ...From April next year, prices for already-listed generics will fall to about 51% of the original drug's price, from a current maximum of 53.55%. Prices will then be lowered in stages to 45%, while the second phase of cuts will proceed as originally planned, starting in 2030 and running through 2036... Full

 

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