Monday, November 9, 2026

 

 

Teva's 3 Key Branded Drugs Grew Sales 33% Last Quarter. Is This Turnaround Stock a Buy Right Now?

(11/6, James Haley, The Motley Fool) ...Thanks to an emphasis on higher-margin therapies, the company appears to be back on track. Its shares are up more than 34% so far this year...Maintaining growth depends entirely on the continued commercial ramp of its innovative portfolio, supplemented by recent product approvals such as Weltruza to offset the natural drag of legacy commoditized generics. However, the company appears headed in the right direction and, despite its rise this year, remains a bargain... Full

 

 

BIO Joins the Legal Fight Against Medicare Pilot That Ties Drug Prices to Peer Countries

(11/7, John Wilkerson, STAT) ...BIO and two California-based biotech trade groups filed a complaint Friday in the U.S. District Court for the Northern District of California asserting that the Global Benchmark for Efficient Drug Pricing demonstration, known as GLOBE, oversteps Medicare's statutory authority. The complaint seeks to halt the model... Sub. Req'd

 

Democrats Are Poised for a Fight Over Healthcare Next Congress

(11/9, Erin Durkin, Bloomberg Government) ...Progressive candidates like Senator-elect Abdul El-Sayed in Michigan won difficult races last week on promises to provide healthcare to all Americans through a single-payer healthcare system — but they will need to get their colleagues on board... Sub. Req'd

 

Policy Analysts: Few Major Bipartisan Dug-Pricing Bills Expected As Dems Craft Health Agenda

(11/6, Lauren Brensel, Inside Health Policy) ...Since Democrats agree in principle with MFN pricing, just not Trump's secretive approach, codifying TrumpRx could be viewed as a bargaining chip. There are a few opportunities in Congress for bipartisan agreement on less grandiose drug-pricing reforms, though, including the user fee reauthorizations for prescription drugs, biosimilars, generic drugs and medical devices that need to pass before September 2027... Sub. Req'd

 

CMS Makes it Official, Codifying Medicare Drug Price Negotiations Established Under IRA

(11/6, Fraiser Kansteiner, Fierce Pharma) ...The final rule is slated to go into effect Dec. 5, CMS said in a fact sheet accompanying Thursday's announcement. By Feb. 1 of next year, CMS will select up to 20 drugs covered under Medicare Part B or Part D for price negotiations taking effect in 2029, with the potential to also select medicines included in previous rounds for renegotiation... Full

 

CMS Retains 'Value Of 12' For One-Time Therapies In Medicare Price Negotiation Despite Pushback

(11/6, Maaisha Osman, Pink Sheet) ...The final rule, scheduled for Federal Register publication Nov. 9, will move the Medicare Drug Price Negotiation Program from sub-regulatory guidance to permanent regulation. Statutory authority to run the program through guidance expires at the end of 2028... Global Sub. Full

 

The US Drug-Pricing Reset: Competing on Net Value

(11/6, Partha Anbil, PharmExec.com) ...US drug pricing has crossed an important threshold. The issue is no longer whether intervention occurs, the question is how several interventions interact with portfolio strategy, evidence generation, contracting, and supply continuity... Full

 

FDA Official: Surprise Foreign Inspections Ramped Up, More To Come

(11/6, Inside Health Policy) ...Elizabeth Miller, associate commissioner, at the agency's Office of Inspections and Investigations (OII), told drug industry members at the Association for Accessible Medicines (AAM) generics and biosimilars conference that the number of inspections in India nearly doubled over the past fiscal year, while visits tripled in China. "The point is not surprise for surprise sake," she said Tuesday (Nov. 3). "The point is to observe ordinary operating petitions, strengthen confidence in the evidence we collect and create more level of inspectorate posture between the domestic and foreign facilities."... Sub. Req'd

 

 

FDA Approves Weltruza, First Once-Monthly Subcutaneous Olanzapine Injection for Schizophrenia

(11/6, Logan Lutton, Managed Healthcare Executive) ..."Weltruza combines proven science and novel formulation innovation to eliminate the need for monitoring after each injection, addressing a significant barrier to treatment and advancing care for people living with schizophrenia," Eric Hughes, M.D., Ph.D., executive vice president of global R&D and chief medical officer at Teva, said in the news release... Full

 

J&J's Once-Daily Pill Eases Psoriatic Arthritis Symptoms in Late-Stage Trial

(11/7, Padmanabhan Ananthan, Reuters) ...The company said 58% of patients who took icotrokinra, branded as Icotyde, saw a 20% improvement in tender and swollen joint counts, as well as improvements in other measures of disease activity after 16 weeks. That compared with 41% who received a placebo in the 552-patient trial... Full

 

BE BOLD: BIMZELX® (Bimekizumab-bkzx) Builds on Superior Joint Responses Versus SKYRIZI® (Risankizumab-rzaa) at Week 16, with Clinical Improvements Sustained Through Week 24

(11/9, UCB) ...UCB, a global biopharmaceutical company, today announced Week 24 data for BIMZELX® (bimekizumab-bkzx) from BE BOLD, building on the study's previously reported Week 16 results, which demonstrated statistically significant superiority in ACR50 joint outcomes versus risankizumab at Week 16 in psoriatic arthritis (PsA)... Full

 

Real-World South Korean Surveillance Evaluates Fremanezumab for Migraine Prevention

(11/7, Bioengineer.org) ...Among the 1,096 patients assessed for effectiveness, fremanezumab treatment led to an average reduction of 7.8 monthly migraine days from baseline... Full

 

 

Samsung Bioepis Unveils Keytruda Biosimilar Data, Targets US and Korea Markets

(11/9, Hong Da-yeong, ChosunBiz) ...Samsung Bioepis conducted a phase 3 trial on 555 patients with metastatic non-squamous non-small cell lung cancer. When comparing the proportion of patients whose tumors shrank at week 24 of treatment, it confirmed that Keytruda and the biosimilar showed almost similar efficacy. The rate of serious adverse events was also similar to Keytruda... Full

 

Samsung Bioepis: Building a US Biosimilar Market That Lasts

(11/6, Patrick Burton, Pharma Boardroom) ...Tom 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

 

Celltrion's Steqeyma Wins EU Panel Backing for Broader Pediatric Use

(11/9, Kim Yoon-mi, Korea Biomedical Review) ...Celltrion said Monday that a European regulatory panel has recommended expanding the approved uses of its Stelara biosimilar Steqeyma (ustekinumab) to treat Crohn's disease and ulcerative colitis in children aged two and older... Full

 

New Real-World Evidence Presented by Organon at the American College of Rheumatology (ACR) Annual Meeting Evaluated a Large-Scale Switch to HADLIMA® (adalimumab-bwwd) Across United States Veterans Affairs Healthcare System

(11/7, Organon) ...The poster evaluates the treatment, management, and economic impacts of transitioning patients from originator HUMIRA® (adalimumab) to biosimilar HADLIMA® (adalimumab-bwwd) within the United States (US) Department of Veterans Affairs (VA) Healthcare System... Full

 

 

With an Approval Apiece, the Verdict Is Still out on AbbVie's and BMS' Twin Neuro Buys

(11/9, Tristan Manalac, BioSpace) ...Earlier this fall, the FDA approved AbbVie's Parkinson's disease drug Juvmo—formerly tavapadon — prompting analysts and observers to revisit the pharma's $8.7 billion takeover of Cerevel Therapeutics, along with a parallel transaction: Bristol Myers Squibb's $14 billion buyout of Karuna Therapeutics. But at least one analyst says it's too early for a reckoning on either transaction. "It's still early days, but as of today, I don't think there's a clear winner," Graig Suvannavejh, managing director and senior biotech and biopharma analyst at Mizuho Securities, told BioSpace... Full

 

Biocon Shakes Up Senior Leadership As Q2 Net Profits Fall 52%

(11/6, Urte Fultinaviciute, Generics Bulletin) ...Presenting earnings for the quarter ended Sep. 30, 2026, CEO Shreehas Tambe announced that Biocon has streamlined its commercial organization to "make it leaner and bring us closer to our customers." Specifically, Matt Erick, chief commercial officer for advanced markets, has left the company to "pursue opportunities outside Biocon," said Tambe, adding that they have "worked closely for over the past five years to build our biologics business in advanced markets." Erick was not present during the earnings call, suggesting the departure was immediate... Global Sub. Full

 

More than Family Business: Drugmakers Make Costly, Long-Term Strategic Shifts as Next Generation Steps into Bigger Roles

(11/8, Shilpa Ranipeta, The Economic Times) ...Laurus Labs' contract development and manufacturing revenue rose 36% in 2025-26 as it expanded capacity. Granules India is investing in complex generics and peptide manufacturing. Bharat Biotech is looking beyond vaccines to advanced therapeutics. All of these moves coincide with the next generation taking on larger roles at these companies... Full

 

 

EU Pharma Sandbox Plans Risk National Regulatory Pushback, EFPIA Warns

(11/6, Dean Rudge, Pink Sheet) ...Drug developers could face fresh scrutiny from national regulators in Europe when seeking approval to run clinical trials under plans agreed via the EU's new regulatory sandboxes, the European Federation of Pharmaceutical Industries and Associations has warned... Global Sub. Full

 

MFN: EU Anti-Coercion Instrument Could Counter US Drug Pricing Threats

(11/6, Francesca Bruce, Pink Sheet) ...The EU should use its Anti-Coercion Instrument to counter US "economic coercion" through the country's most favored nation (MFN) drug pricing policy and its US Trade Representative (USTR) investigation into German pricing and reimbursement policies, says Frank Vandenbroucke, Belgium's deputy prime minister and public health minister... Global Sub. Full

 

Is Trump's Most-Favoured-Nation Drug Policy Keeping Medicine From Canada? Evidence Is Mixed

(11/9, Chris Hannay, The Globe and Mail) ..."MFN accentuates the vulnerabilities of Canada when it comes to drug launches," said Bettina Hamelin, chief executive officer of Innovative Medicines Canada, the main lobby group for patented drug makers... Sub. Req'd

 

Generic Drugs, Implants & Injectables Being Studied: Maharashtra FDA Commissioner

(11/6, PT Jyothi Datta, The Hindu BusinessLine) ...In less than six months of Tukaram Mundhe taking charge as Maharashtra Food and Drug Administration's Commissioner, the regulatory authority has undertaken over 33,000 inspections, close to 8,000 of them involving medicines. But there's more scrutiny coming up of segments that include generic drugs, injectables and implants, Mundhe told businessline... Full

 

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