Monday, March 9, 2026

 

 

There Is 'Much to Be Bullish About' this Pharma Stock: Analyst

(3/6, StreetInsider.com) ...Teva's outlook reflects "an attractive long-term top-line/EBITDA growth story coming into focus, in the context of continued improvement in the capital structure and an absence of loss of exclusivity exposure," [Piper Sandler analyst David Amsellem] wrote. He also pointed to expectations for further valuation expansion from current levels as the company executes on its strategy...According to Amsellem, Teva is prioritizing incremental innovation rather than pursuing high-risk early discovery programs. The strategy emphasizes developing novel molecular entities that target validated biological pathways while improving drug performance... Sub. Req’d

 

 

Democrats Press 11 Pharmas for 'Any Evidence' Their Trump Pricing Deals Deliver Savings for Medicaid

(3/5, Fraiser Kansteiner, Fierce Pharma) ...Backed by six other Senate Democrats, [Sen. Ron] Wyden has sent out 11 letters to as many pharmaceutical makers, seeking clarity on whether there is "any evidence that these deals will benefit American patients and taxpayers in terms of savings to the Medicaid program," according to a March 6 press release...According to the Senate Finance Committee, letters have been sent out to AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Roche's Genentech, Gilead Sciences, GSK, Johnson & Johnson, Merck & Co., Novartis and Sanofi... Full

 

FDA Plans to Loosen Testing Rules to Boost Biosimilar Drugs

(3/9, John Tozzi, Bloomberg) ...The FDA expects to issue draft guidance as soon as Monday, said the official, who declined to be named because the information is not yet public... Sub. Req’d

 

GDUFA IV: Sponsors May See ANDA Prioritization If Some Production Aspects Onshored

(3/6, Derrick Gingery, Pink Sheet) ...Rather than meet all three requirements of pivotal bioequivalence testing conducted in the US or waived, and finished dosage form manufacturing and active pharmaceutical ingredient suppliers located in the US, the FDA said manufacturers could meet two of the three and receive a priority review, according to minutes of a Feb. 4 negotiating session... Global Sub. Full

 

FDA Drafts Guidance on Best Practices for Responding to Inspection Observations

(3/6, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection. This guidance applies to both domestic and international inspections... Full

 

Vinay Prasad, Controversial FDA Leader, to Again Depart Agency

(3/6, BioPharma DIVE) ...Prasad's coming exit is "likely to be received positively," wrote RBC Capital Markets analyst Brian Abrahams, in a Friday note to clients...But his departure "perpetuates the regulatory leadership volatility that has kept companies uncertain about their developmental direction and many investors on the sidelines," Abrahams added. "Prasad's replacement — even if a bit more lenient — would likely still mirror" the views Makary and the agency currently have, he warned... Full

 

Prasad Out At FDA, Turning Critics' Focus Back To Makary

(3/6, Jessica Karins, Maaisha Osman, Inside Health Policy) ...Diana Zuckerman, president of the National Center for Health Research, told IHP Prasad's departure from CBER represents a setback for efforts to strengthen scientific rigor in the agency's regulatory decisions. She said Prasad brought a focus on scientific evidence that many researchers and policy experts have long argued has been missing at senior levels of FDA...In her view, the agency's reliance on more "flexible" approval standards for products that lack clear evidence of benefit is contributing to rising health care costs and straining federal programs such as Medicare and Medicaid. "I think Dr. Prasad leaving is a loss for the FDA, for patients, and for Medicare and Medicaid," Zuckerman said... Sub. Req’d

 

Top FDA Drug Official Is Trying to Hire a Friend Who's Seeking a Warning About Unproven Side Effects of Antidepressants

(3/9, Associated Press) ...The Food and Drug Administration's top drug regulator, Dr. Tracy Beth Hoeg, is working to hire a researcher and friend who wants the agency to add new warnings to antidepressants about unproven pregnancy risks, The Associated Press has learned. Dr. Adam Urato, a maternal-fetal medicine specialist and critic of antidepressant safety, is pressing the FDA to add a boxed warning to SSRIs, the drugs most commonly prescribed for depression... Full

 

FDA Holds Meeting with States on Importation of Lower Cost Drugs

(3/6, FDA) ...Earlier this week, the U.S. [FDA] held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer. The gathering was the latest step toward the FDA's implementation of President's Trump's executive order on lowering drug prices... Full

 

Virginia's Prescription Drug Affordability Board Needs Guardrails to Protect Patient Access

(3/9, Richard Ingram, Virginia Mercury) ...Lawmakers in Richmond can help patients by enacting policies that alleviate this financial burden, and I share the goal behind proposals to create a Prescription Drug Affordability Board (PDAB)... Full

 

 

Roche Shares Fall After Breast-Cancer Treatment Misses Goal in Late-Stage Study

(3/9, Adrià Calatayud, The Wall Street Journal) ...The company said the combination of its investigational giredestrant with Pfizer's Ibrance didn't meet the primary objective of a statistically significant improvement in progression-free survival in patients with advanced breast cancer. In the late-stage trial, the combination was compared against a combination of Ibrance with Novartis's Femara... Full

 

 

Celltrion Drives Asia Biosimilar Gains with Tender Wins and Singapore Lead

(3/9, Hong Da-yeong, Chosun Biz) ...Celltrion said on the 9th that Remsima, its autoimmune disease treatment, recorded a 95% market share in Singapore in the third quarter of last year. According to IQVIA, a pharmaceutical market research firm, Remsima also had high shares in Hong Kong (77%), Thailand (73%), and Malaysia (65%). Remsima is a biosimilar of Johnson & Johnson's Remicade... Full

 

Aspen Aiming 'To Be In The Mix' As Generic Semaglutide Reaches Canada Soon

(3/6, Dean Rudge, Generics Bulletin) ...CEO Stephen Saad told investors that Aspen believes it is well placed to move quickly once regulatory pathways open. "So May-June might be the earliest products you could see there - that's our best estimate. We're hoping to be in the mix towards the end of Q2 or into Q3 to get registration," Saad said... Global Sub. Full

 

Sandoz Moves In On Canadian And Brazilian Semaglutide Opportunity

(3/6, Dean Rudge, Generics Bulletin) ...Speaking as the company delivered its full-year financial results last week, CEO Richard Saynor pointed to GLP-1s as part of a broader wave of loss-of-exclusivity opportunities that the firm expects to target over the coming decade alongside biosimilars and traditional generics...Sandoz is already positioning itself for eventual entry into the GLP-1 space, with filings submitted in markets including Canada and Brazil via partnerships... Global Sub. Full

 

Canadian Company Seeks to Stand Out With Domestically-Made Generic Ozempic

(3/8, Julia Wong, CBC) ..."You could say we're betting everything on this one drug," said David Suchon, co-founder of Toronto-based Vimy Pharma. The company's endeavour highlights domestic pharmaceutical manufacturing capabilities at a time of geopolitical uncertainties and tariff turmoil...Vimy Pharma expects to file its application for generic semaglutide to Health Canada in the coming weeks... Full

 

Cipla's US Unit Recalls 400+ Cartons of Generic Anti-Cancer Drug: USFDA

(3/8, PTI) ...A US-based subsidiary of drugmaker Cipla is recalling over 400 cartons of generic anti-cancer medication due to a manufacturing issue, according to the US [FDA]. Warren (New Jersey)-based Cipla USA, Inc is recalling Nilotinib Capsules in two strengths (150 mg and 200 mg), the US health regulator said in its latest Enforcement Report. The company is recalling the affected lot (271 and 164 cartons) due to "failed tablet/capsule specifications", it stated... Full

 

Celltrion Biosimilars Secure Leading Share in Key Asian Countries

(3/9, Lee Han-soo, Korea Biomedical Review) ...Celltrion's flagship therapy, Remsima (infliximab), has demonstrated strong market performance, with high market shares in Asia. According to IQVIA, a pharmaceutical market research firm, as of the third quarter of 2025, Remsima held market shares of 93 percent in Singapore, 77 percent in Hong Kong, 73 percent in Thailand, and 65 percent in Malaysia... Full

 

 

Servier to Build Cancer Drug Pipeline with $2.5B Purchase of Day One

(3/9, Jacob Bell, BioPharma DIVE) ...The deal, announced Friday, has Servier paying in cash $21.50 for each share of Day One Biopharmaceuticals. That's a 68% premium to Day One's previous closing share price and represents a total equity value of around $2.5 billion. The companies expect to close sometime between April and the end of June... Full

 

Sanofi Strikes Deal with Brazil's EMS to Sell Generics Manufacturer Medley

(3/6, Eric Sagonowsky, Fierce Pharma) ...Sanofi has agreed to sell its Medley generics unit in Brazil to leading local drugmaker EMS, according to an announcement from international law firm Mayer Brown, which advised EMS... Full

 

GSK Sells Rights to Drug Candidate to Alfasigma for Up to $690 Million

(3/9, Adrià Calatayud, The Wall Street Journal) ...GSK said it would sell rights to linerixibat, an experimental treatment for itching caused by a liver disease, to Italian pharmaceutical company Alfasigma as part of a licensing agreement valued at up to $690 million... Full

 

Affordable Medicines To Be Key Driver For Amneal In 2026 As Specialty Takes Back Seat

(3/6, Urte Fultinaviciute, Generics Bulletin) ...As chief financial officer Anastasios Konidaris explained during the firm's Q4 2025 earnings call, Amneal's specialty growth will be paused due to expected generic competition for its Parkinson's disease drug Rytary (carbidopa/levodopa). The follow-on product Crexont and other specialty brands will continue to grow in 2026, but not enough to withstand off-patent challengers... Global Sub. Full

 

Dr Reddy's Says US Justice Dept Has Closed Corruption Probe Without Action

(3/6, CNBCTV18.com) ...Pharma giant Dr Reddy's Laboratories Ltd said the US Department of Justice has closed its inquiry into allegations of improper payments to healthcare professionals without recommending any enforcement action against the company... Full

 

US Pricing ‘Particularly Negative' for Swiss Unit, Says Roche

(3/7, Hugo Miller, Bloomberg Law) ...The effect of Donald Trump's new drug pricing policy requiring drugmakers to match US prices with those elsewhere will be particularly acute on its Swiss business, Roche Holding AG Chairman Severin Schwan told NZZ. "Such scenarios would have particularly negative consequences for our Swiss operations, where we cover many global functions in research and production," Schwan told the paper. "A large portion of our added value and local jobs is financed by our business in the USA. We pay more in taxes in Switzerland than we generate in revenue."... Sub. Req’d

 

Novo Nordisk's Wegovy and Ozempic Shots Could Be Made for as Little as $3 a Month, Analysis Finds

(3/6, Ed Silverman, STAT) ...After reviewing data for active pharmaceutical ingredients from the past two years, the researchers estimated a generic version of semaglutide — the key ingredient in the Ozempic diabetes treatment and Wegovy weight loss drug — could be made for $28 to $140 per person a year and then sold at low prices once patents expire this year in several countries... Full

 

Blue Cross Blue Shield Says Data Back Up Claim That AI Is Driving up Medical Bills

(3/9, Brittany Tang, STAT) ...Now, a new report from a data analysis firm associated with the Blue Cross Blue Shield Association offers the the first possible evidence that AI coding may be behind insurers' increased expenses, and that it may be driving up the cost of health care. The insurer claims AI-driven coding inflation could be the cause of $663 million in additional inpatient spending... Full

 

 

Key Drug Prices May Surge on Hoarding and Higher Demand

(3/7, Teena Thacker, The Economic Times) ...As the military conflict escalates across the Middle East, panic-driven stockpiling and surging demand for essential drugs are likely to inflate drug prices, industry experts said, while Indian pharma companies with operations in the Middle East monitor the situation... Full

 

Shortage of Medicines, Formula Milk Looms Large

(3/9, Tufail Ahmed, The Express Tribune) ...If the war prolongs, importers warn that Pakistan could face severe shortages of medicines and vaccines, which may result in a dramatic increase in drug prices... Full

 

Middle East Crisis to Worsen Shortage of Various Medicines

(3/6, Lakshmi Prabha, Pharmacy Business) ...Nearly 80 percent of NHS prescriptions are generic medicines, and only 25 percent is made in the UK. The rest are sourced from India and China. With the current Middle East crisis leading to the disruption of flights and sea routes, it is bound to have a severe knock-on effect on the generic drugs supply chain. The rising oil prices is bound to increase transportation costs and make drugs even costlier... Full

 

Ireland Strikes New Five-Year Drug Pricing Deals, Speeding Access to Medicines

(3/6, Brian Maguire, Euractiv) ...The agreements, finalised after negotiations between the Department of Health, the Department of Public Expenditure, the Health Service Executive and industry bodies, are intended to address long-standing concerns over drug shortages, lengthy reimbursement timelines and rising expenditure across the Irish health service... Full

 

EMA Pushes For Faster, Safer Clinical Trial Approvals During Public Health Crises

(3/6, Eliza Slawther, Pink Sheet) ...The EMA said that a PHE could necessitate "prompt action" to adapt the conduct of a clinical trial. It added that while trial participant safety should be a priority when adapting trials, the foreseeable benefits that the trial could bring to public health should also be considered... Global Sub. Full

 

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