Wednesday, October 28, 2026

 

 

Teva Picks up New Neuro Assets in Bioxcel's Bankruptcy Sale

(10/27, Elizabeth S. Eaton, FirstWord PHARMA) ...The drugmaker splashed $57.5 million upfront to buy Igalmi (dexmedetomidine), a sublingual film approved by the FDA in 2022 as an in-hospital treatment for agitation associated with schizophrenia or bipolar disorder in adults. Teva is also walking away with worldwide rights to BXCL501..."BXCL501 is a strong strategic fit with our neuroscience portfolio and reflects our disciplined focus on differentiated, late-stage opportunities that address unmet patient needs and create long-term value for Teva's shareholders," said Evan Lippman, Teva's EVP of business development, in a company release... Full

 

Teva Completes Acquisition of BioXcel Assets, Expands Neuroscience Pipeline

(10/27, Patrick Lavery, Contract Pharma) ..."Agitation can escalate quickly," Teva Executive Vice President, Global R&D and Chief Medical Officer Eric Hughes, MD, PhD, said. "The ability to intervene early matters. BXCL501 could give adults living with schizophrenia or bipolar I or II disorder the ability to treat agitation at home. [This is] closer to the moment symptoms emerge, and before they could become more difficult to manage."... Full

 

Teva Swoops for BioXcel Neuroscience Assets in Bankruptcy Sale for Up to USD 125m Ahead of FDA decision

(10/27, Robert McTiernan, AllSci) ...Teva said that, if approved, BXCL501 would be the first FDA-approved treatment patients could use at home for acute agitation associated with schizophrenia or bipolar I or II disorder... Full

 

Roundup: Teva Acquires BXCL501 for $57.5 Million Upfront, Rumi Therapeutics Enters Option Agreement for Fragile X PDE2 Inhibitor From Enthorin

(10/27, Pharmaceutical Executive) ...Teva paid $57.5 million upfront and could owe up to $67.5 million in contingent payments, some tied to the timing of regulatory approval and others to sales milestones... Full

 

Teva Seals Trump Administration API Deal With MFN Pricing Pledge

(10/27, Urte Fultinaviciute, Generics Bulletin) ...Along with API donation, the finalized deal between Teva and US government also included the firm's agreement to lower the cost of select medicines for American patients covered by Medicaid. Teva said that its business was built to deliver affordable medicines and expanded access. As such, "the agreement reflects our commitment to strengthening US medicines supply and ensuring patients have access to affordable medicines today and the innovative treatments they will need tomorrow."... Global Sub. Full

 

US Estrogen Supply Crunch Widens as Women Seek Alternatives to Scarce Patches

(10/28, Mrinalika Roy, Reuters) ...The American Society of Health-System Pharmacists early in September listed multiple estradiol injection products from Hikma, American Regent and Par Sterile Products as being in shortage. Separately, ASHP lists vaginal estradiol creams made by Viatris' Mylan unit, Padagis, and Teva as being on backorder or allocation... Full

 

 

Drug Middlemen Will Soon Have to Share Details on How They Are Paid

(10/28, Anna Wilde Mathews, Liz Essley Whyte, The Wall Street Journal) ...Under a new regulation from the Labor Department expected to be released Thursday, pharmacy-benefit managers will have to provide their employer clients with granular information about the prices they pay for pharmaceuticals, as well as payments they receive from drugmakers, according to people with knowledge of the matter. The new rule is an effort to lower healthcare costs, said a Labor Department official, in line with an executive order from April 2025 and the Trump administration's promise to significantly reform PBMs... Sub. Req'd

 

Industry Backs BsUFA IV, Manufacturing Reforms; FDA Calls It 'Great Agreement'

(10/27, James Noyes, Inside Health Policy) ...Representatives from the Association for Accessible Medicines (AAM), the Biosimilars Forum, Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) were largely in agreement that the broader package would make the biosimilar review process more predictable and give sponsors more opportunities to resolve problems before they delay approval... Sub. Req'd

 

Phathom's Voquezna Tests Limits of US FDA's 'Umbrella' Exclusivity Policy

(10/27, Sue Sutter, Pink Sheet) ...Regulatory and legal disputes involving Phathom Pharmaceuticals' Voquenza (vonoprazan) could have broader implications for the US [FDA's] "umbrella" policy of applying new chemical entity (NCE) exclusivity across products containing the same active moiety. The Office of Generic Drugs seeks comments on several issues involving the intersection of NCE exclusivity, Generating Antibiotic Incentives Now (GAIN) exclusivity, and a carve-out of protected indications from generic drug labeling... Global Sub. Full

 

Missouri AG Warns Lilly to Stop Requiring Data From Hospitals Seeking 340B Drug Discounts

(10/27, Ed Silverman, STAT+) ...Missouri Attorney General Catherine Hanaway (R) has warned Eli Lilly to discontinue its practice of requiring hospitals to provide claims data to receive discounted medicines under a federal program, a sign that more states are pushing back against such moves by drugmakers... Sub. Req'd

 

 

Astellas Gains Option to License Audax's Immuno-Oncology Asset in $1.34B Deal

(10/28, Pavan Kamat, FirstWord PHARMA) ...Under the deal's terms, Astellas will pay Audax $285 million in upfront plus potential option exercise payments, with the latter eligible for an additional $1.05 billion in milestone payments, in addition to tiered double-digit sales royalties... Full

 

What Stands in the Way of Patients with Atopic Dermatitis Getting Prescription Medication? Here Are Some Possibilities

(10/27, Peter Wehrwein, Managed Healthcare Executive) ...Two abstracts slated for presentation at the meeting, which is called AMCP Nexus, pointed to managed care practices, such as prior authorization and formulary placement, as barriers. Research summarized in another abstract identified access problems in rural areas. Another abstract based on a focus-group-like program organized by the AMCP called AMCP Market Insights pointed to limited access to dermatologists... Full

 

 

Cipla Targets First Wave Launch for Keytruda Biosimilar; Sees 5% Monthly Gain in Yurpeak Sales

(10/28, ETPharma.com) ...Steeping up its oncology plans, Cipla is targeting a first wave launch of its in-licensed Keytruda biosimilar 'QL2107' in the US market post patent expiry in 2029. Speaking to reporters post second quarter FY27 results, Achin Gupta, Global CEO and MD said, "we are among the first wave of launches and … the go to market opportunity positions us to capture significant share of market... Full

 

Regeneron, Amgen Further Narrow Lawsuit Over Eylea Biosimilars

(10/27, Nino Paoli, Bloomberg Law) ...The parties said they reached an agreement to dismiss all claims and prayers for relief over Regeneron's US Patent Nos. 9,816,110 and 11,788,102, which the court approved Tuesday. They also told the US District Court for the Northern District of West Virginia that the counterclaims should be dismissed without prejudice... Sub. Req'd

 

 

GSK Sales Get Boost From Specialty Medicines

(10/28, Adrià Calatayud, The Wall Street Journal) ...GSK reported an increase in third-quarter sales, boosted by its specialty medicines segment, as the U.K. drugmaker works to cut costs and speed up the development of its drug pipeline...A jump in sales of specialty medicines allowed GSK to offset a declining vaccines revenue and a flat performance in its general medicines segment... Sub. Req'd

 

Novartis CEO Keeps Faith in Avidity Deal Despite Taking $1.9b Hit from Del-Desiran Fail

(10/27, James Waldron, Fierce Biotech) ..."It's hit a bump, which is normal, I think, when you're trying to do pioneering science," the CEO said on the call. "That doesn't change our conviction around antibody oligos and the ability to address neuromuscular disease."... Full

 

Generic Drugmaker Sandoz's Shares Fall After Sales Outlook Lowered

(10/28, Reuters) ...Particularly its biosimilars unit slightly fell short of expectations with net sales reaching $998 million, a 17% jump at constant exchange rates compared with the same period last year, but below the $1.02 billion analysts had forecast... Full

 

Samsung Bioepis Operating Profit Jumps 21% on Biosimilar Sales

(10/28, Park Su-hyeon, The Chosun Daily) ...Samsung Bioepis increased its operating profit by more than 20% in the third quarter of this year, excluding milestone revenue. The expansion of global sales of Soliris and Stelara biosimilars drove the improvement in performance... Full

 

Celltrion Hits Record Q3 Earnings on New Biosimilars

(10/28, Choi Mun-hee, BusinessKorea) ...The key driver of the earnings improvement was the portfolio of new biosimilar products launched since last year. Combined sales of five new product groups — Steqeyma, Omlyclo, Eydenzelt, Stoboclo and Osenvelt, and Avtozma — reached 388 billion won, surging 335% year on year. Stovoclo and Osenvelt are grouped together as products containing the same active ingredient. New products accounted for 67% of total biosimilar revenue in the third quarter. Rising sales of high-margin products and an improved product mix have boosted profitability, accelerating the shift away from a revenue structure centered on legacy products... Full

 

Lupin's Global Ambitions Rest on Innovation and Specialty Medicines

(10/27, Neetu Chandra Sharma, Business Today) ...For Vinita Gupta, Lupin's Chief Executive Officer, who helped transform the company from a largely India-focused business into a global player, the focus now is on preparing it for its next phase of growth... Full

 

Mankind's Growth Strategy Puts Chronic Drugs, Specialty Portfolio In Focus

(10/28, Sushmita Panda, Generics Bulletin) ...During its second quarter earnings call, management reiterated its target of increasing chronic therapies' share of its domestic portfolio from 39% to 50%. The Indian drugmaker maintained that it remains committed to the target, with plans to drive domestic growth through its chronic therapies and hospital businesses... Global Sub. Full

 

Fresh Off an IPO and Launching a Generic GLP-1, Apotex CEO Jeff Watson Has Even Bigger Plans

(10/27, Trevor Cole, The Globe and Mail) ...Circumstances don't get much rockier than the ones Jeff Watson faced when he first took the top job at Apotex in early 2018. Canada's biggest generic-drug maker was still reeling from the murder of its 75-year-old founder, Barry Sherman, and his wife, Honey. On top of that, CEO Jeremy Desai had resigned amid accusations of stealing trade secrets from a rival. The man who replaced him, Jack Kay, had just been pushed out by the founder's heirs. But like the CFL offensive lineman he once was, Watson held the line...Now, at 62, he's leading a 52-year-old pharma giant finding its feet as a public company entering an unprecedented period of opportunity. And its GLP-1 drug is just the start. We spoke to him at his office in Toronto... Sub. Req'd

 

Enveda, Anthropic Take Aim at Drug-Development Bottlenecks with Claude

(10/27, Anna Bratulic, FirstWord PHARMA) ...In an internal evaluation, Enveda said Claude-powered workflows cut batch-record review times by 89% — from almost 26 hours for four Enveda reviewers to just under three hours — and produced a first draft of regulatory content in hours rather than months... Full

 

Anthropic Says It Will Revolutionize Biology—Some Day

(10/27, WIRED) ...The IPO filing indicates that Anthropic no longer sees itself solely as an outside provider of AI tools to the biotech industry; it sees biotech discovery as a core part of its business model. And like all biotech companies, it faces the long timeline of drug development... Full

 

 

MFN Drug Policy Cuts US Costs; It May Block Europe's First Sjögren's Therapy

(10/27, Benjamin Eddie, Tech Times) ...Novartis CEO Vasant Narasimhan said Tuesday on the Swiss drugmaker's third-quarter 2026 investor call that bypassing Europe's government-run payers entirely for certain pipeline drugs is "not off the table," citing the Most Favored Nation drug pricing policy as the structural driver... Full

 

EU Plan To Ease Cross-Border Trial Participation Gathers Pace

(10/27, Vibha Sharma, Pink Sheet) ...A multi-stakeholder initiative aimed at helping European patients access clinical trials in other EU countries when no suitable study is available locally is entering a more practical phase... Global Sub. Full

 

Sandoz Warns EU May Scrap Antibiotic Protection, Risking Plant

(10/28, Isabel Demetz, Naomi Kresge, Bloomberg) ...Sandoz Group AG said Europe's medicines regulator is proposing to pull amoxicillin from its list of critical medicines, a potential death blow to the last European factory to make the antibiotic from scratch. Removing the medicine, which is part of the penicillin family, from the list would expose Swiss drugmaker Sandoz to even greater competition from Chinese and Indian rivals. "We're now literally on one minute to midnight to deciding whether we continue to stay in Europe making penicillin," Chief Executive Officer Richard Saynor said in an interview... Sub. Req'd

 

Wockhardt's Habil Khorakiwala Bats for Innovation-Led Pharma Growth, Calls for Regulatory Overhaul

(10/28, Moneycontrol) ...Speaking at the News18 Rising Bharat Summit in Mumbai on October 28, [Wockhardt Founder Dr. Habil] Khorakiwala said India has the scientific talent and entrepreneurial capabilities to compete globally in pharmaceutical innovation but lacks the ecosystem to support the discovery and development of breakthrough medicines... Full

 

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