Friday, October 9, 2026

 

 

Teva Wins FDA Approval for Monthly Schizophrenia Injection Weltruza

(10/9, Reuters) ...Teva said on Friday it had received approval from the US Food and Drug Administration for its Weltruza drug for extended-release injectable suspension as the first and only once-monthly subcutaneous injectable olanzapine for adults with schizophrenia... Full

 

Teva Announces FDA Approval for Weltruza

(10/9, The Fly) ...In the coming weeks, Weltruza will be available in three different strengths with no loading doses, no oral supplementation and no post-injection monitoring required... Sub. Req'd

 

Inside Teva's Denosumab Biosimilar Strategy: Robert Cook, PhD

(10/8, Sabrina McCrear, Rob Cook, PhD, The Center for Biosimilars) ...Teva's Robert Cook, PhD, explains the clinical data, interchangeability, and supply strategy behind its Degevma and Ponlimsi biosimilars... Full

 

 

Stakeholders Question Drug Makers After PhRMA Sues Over Scaled-Back GLOBE Model

(10/8, Gabrielle Wanneh, Inside Health Policy) ..."Over the past year, drugmakers have smiled for the cameras in the Oval Office as they announced new MFN deals. Now, Big Pharma takes President Trump's administration to court to block the GLOBE program, which would implement MFN policy for certain Medicare-covered drugs and lower prices," PRA spokesperson and former House Rep. J.D. Hayworth (R-AZ) said in a statement on the lawsuit Wednesday (Oct. 7). "So, which is it? Does Big Pharma support MFN or have they been untrustworthy and playing the Washington game this whole time?"... Sub. Req'd

 

The Cost of Drugs From Canada Is Set to Soar for Millions of Americans Because of a Federal Rule

(10/8, Fatima Hussein, Associated Press) ...The U.S. Customs and Border Protection rule targets the de minimis exemption, which previously allowed shipments valued under $800 to pass through customs more easily. As of Oct. 22, that exemption will be indefinitely suspended, and medications mailed from outside the U.S. will require additional data and a bond guarantee. Many medications have already increased in price since customs rules went into effect in August 2025. However, the Oct. 22 compliance date includes importation rules that could eliminate the ability to import personal prescriptions... Full

 

New PDUFA Deal Allots Money to Rehire FDA Reviewers, Trade Groups Say

(10/9, Max Bayer, Endpoints News) ...Lucy Vereshchagina, executive vice president of science and regulatory advocacy at PhRMA, outlined the funding expectation in a briefing with reporters on Wednesday. "We agreed that FDA will set aside money specifically that can only be used to hire and retain staff to help ensure that staffing levels return to the level funded in PDUFA VII," she said. The latest agreement, PDUFA VIII, would run from fiscal 2028 to 2032... Sub. Req'd

 

Experts Weigh in on FDA's Transparency Roadmap

(10/8, Joanne S. Eglovitch, Regulatory Focus) ...The roadmap was supported by former FDA Commissioner Joshua Sharfstein, who told Focus that "the FDA's new roadmap is a meaningful step forward for transparency at FDA. It recognizes that in one fell swoop, greater sharing of information and agency decision making benefits patients and clinicians, researchers, and regulated industry. I hope that FDA continues moving in this direction as there are important opportunities for progress."... Full

 

 

Johnson & Johnson Releases 2-year Psoriasis Drug Data at Dermatology Meeting

(10/9, StreetInsider.com) ...The study tracked 684 participants aged 12 and older, including 66 adolescents. At Week 112, at least 72% of ICOTYDE-treated patients achieved a Psoriasis Area and Severity Index (PASI) score improvement of 90%, and at least 70% achieved clear or almost clear skin as measured by the Investigator's Global Assessment. Complete skin clearance was recorded in at least 44% of patients, while 78% sustained clinically meaningful itch improvement from Week 64 through Week 112... Sub. Req'd

 

Prifemilast Demonstrates Superior Efficacy vs. Apremilast in Newsoara's Head-to-Head Phase 3 Psoriasis Trial; cAMPfield Advancing the Potential Best-in-Class Oral PDE4 Inhibitor in IBD

(10/9, cAMPfield Therapeutics) ...In a head-to-head Phase 3 trial, prifemilast nearly doubled the rate of PASI 75 response compared with apremilast and achieved superiority on both co-primary endpoints... Full

 

Four Deaths Behind FDA's Decision to Pause Pivotal Schizophrenia Study of Newron's Evenamide

(10/8, Matthew Dennis, FirstWord PHARMA) ...Newron Pharmaceuticals disclosed that the FDA is concerned about the death of four patients in clinical studies of evenamide, a signal that prompted the agency to place a hold on a Phase III trial of the glutamate modulator for treatment-resistant schizophrenia earlier this year... Full

 

Pfizer's Tukysa Snags First-Line Approval in HER2+ Breast Cancer Maintenance

(10/8, Donavyn Coffey, Fierce Pharma) ...Tukysa won the FDA green light Wednesday for U.S. patients with advanced HER2-positive breast cancer that is not amenable to surgery or has metastasized to distant organs. The current standard of care in theses cases is to lead with induction chemotherapy plus Roche's two HER2 antibody drugs, Herceptin and Perjeta, and follow with a chemo-free maintenance phase using the two Roche drugs. The FDA approval now includes Tukysa as a beneficial addition to the chemo-free maintenance period... Full

 

Argenx Shares Plunge On Clinical Trial's Halt

(10/9, Adria Calatayud, The Wall Street Journal) ...Argenx shares closed down nearly 12% Thursday on the Nasdaq, wiping out the stock's gains in the year to date... Sub. Req'd

 

Solengepras Meets Primary Endpoint in Phase 3 ARISE Trial of Parkinson Disease

(10/8, Marco Meglio, NeurologyLive) ...In the movement disorder realm, the phase 3 ARISE trial met its primary endpoint, with once-daily oral solengepras (Cerevance) 150 mg significantly reducing OFF time compared with placebo in patients with Parkinson disease (PD) who experience motor fluctuations. Cerevance, which develops solengepras, presented the results at the 2026 International Congress of Parkinson's Disease and Movement Disorders (MDS Congress) in Seoul, South Korea... Full

 

FDA Approves IV, Subcutaneous Atezolizumab for dMMR Colon Cancer

(10/8, Giuliana Grossi, AJMC) ...The FDA approved atezolizumab (Tecentriq; Genentech) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients 2 years of age and older with stage III mismatch repair deficient (dMMR) colon cancer.1 The approval was announced October 8, 2026... Full

 

 

Samsung Bioepis: Building a US Biosimilar Market That Lasts

(10/8, Patrick Burton, Pharma Boardroom) ...As the US biosimilar market matures, Samsung Bioepis is accelerating its expansion, with ten FDA approvals so far, seven assets in development, and an ambitious target of 20 products on the market by 2030. Thomas Newcomer, SVP and Head of US Commercial, sets out why quality and supply reliability, rather than low prices, are at the heart of this vision... Full

 

Lupin Receives U.S. FDA Approval for Phytonadione Injectable Emulsion, USP

(10/8, Lupin Pharmaceuticals, Inc.) ...The U.S. FDA has approved Lupin's Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe as bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, of International Medication Systems, Limited and is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K-deficiency... Full

 

Thyme Companies Launches First New Venture, Thyme Therapeutics, To Build a More Sustainable, Lower-Cost Oncology Biosimilar Model

(10/8, Thyme Companies) ...The company will work closely with oncologists, health plans, and manufacturers to commercialize oncology biosimilars. Its model will help patients access more affordable care, make lower-cost treatments easier for oncologists to adopt, and reduce overall healthcare costs... Full

 

 

Merck Barred from Making Subcutaneous Keytruda in 8 European Countries

(10/8, Nick Paul taylor, BioSpace) ...The court found Merck's drug, which European authorities approved in November, infringes a Halozyme Therapeutics patent. Having reached that conclusion, the patent court ordered Merck not to produce or sell the subcutaneous product in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland or the Netherlands... Full

 

Pharma's $500B Patent Problem Will Come in Waves — Not as a Cliff

(10/8, Sy Mukherjee, PharmaVoice) ...The amount of worldwide prescription drug sales that Evaluate says are potentially at risk from generic competition between 2026 and 2032. The number underscores the scale of the revenue overhang facing the industry as some of its biggest products move closer to the end of their protected commercial lives. And the exposure is not concentrated in just one year. Instead, the forecast shows a multiyear buildup that stretches from the late 2020s into the early 2030s... Full

 

 

Countdown Begins To Naming The EMA's Next Chief

(10/8, Neena Brizmohun, Pink Sheet) ...Following interviews with shortlisted contenders, the person nominated for the post is expected to appear before the parliament in December this year or January 2027 before being formally appointed... Sub. Req'd

 

Chiesi UK and Ireland Supports NHS Workforce to Address COPD Diagnosis Backlog

(10/8, PMLiVE) ...The Chiesi 'COSMIC (COPD Spirometry Management Supported by AI in a Community Setting)' programme will provide access to ArtiQ.Spiro through collaborative working projects and donations, and will focus on increasing NHS access to high-quality spirometry to strengthen the workforce's diagnostic capacity and support patients with access to timely diagnosis... Full

 

Smaller European Countries Call For Company HTA Submissions Following JCA Reports

(10/8, Dean Rudge, Pink Sheet) ...JCAs mark a big shift in the EU pricing and reimbursement space and how companies prepare for market access... Sub. Req'd

 

Calls for Update to Generic Drug Prices in Portugal

(10/8, Íris Marçal, The Portugal News) ...In a statement, the Portuguese Association for Medicines for Health Equity (Equalmed) says the sector's sustainability requires government intervention, given rising energy and logistics costs, inflation, and disruptions in production and supply chains... Full

 

India's Pharma Industry Looks Beyond US as Trade Uncertainty Grows, Says GlobalData

(10/9, Shankar Besta, Global Data) ...Edita Hamzic, Healthcare Analyst at GlobalData, comments: "This is less about India pivoting away from the US and more about its pharmaceutical companies giving themselves more options. As trade tariffs come down in markets such as the UK, Europe and New Zealand, Indian manufacturers have an opportunity to capture a greater share of global pharmaceutical demand."... Full

 

Cancer Drug Prices May Fall as Government Plans 30% Trade Margin Cap

(10/9, Rupali Mukherjee, The Times of India) ...In a move that could substantially reduce patient bills, govt has decided to cap trade margins at 30% of MRP for all cancer drugs, covering essential, non-scheduled, branded and generic medicines, as well as domestic and patented drugs. This could slash MRPs of life-saving cancer drugs by 20-70%, and result in annual savings of Rs 2,500 crore, while improving affordability and ensuring their continued availability, officials told TOI... Full

 

CPHI Milan: Beyond Generics, How Indian Pharma Is Rewriting Its Global Playbook

(10/8, Shariq Khan, The Economic Times) ...In today's turbulent economic environment, the opportunity for Indian drugmakers is no longer limited to manufacturing medicines at lower costs for overseas markets and selling them overseas, companies at the expo told The Economic Times Digital. They said the focus is now shifting towards becoming strategic partners to global drugmakers through R&D, CDMO (contract development and manufacturing), licensing, co-development and access to regulated markets... Full

 

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