Friday, April 10, 2026

 

 

Teva Pharma (TEVA) PT Raised to $42 at BofA Securities

(4/9, StreetInsider.com) ...BofA Securities analyst Jason Gerberry raised the price target on Teva Pharma to $42.00 (from $38.00) while maintaining a Buy rating... Sub. Req’d

 

 

US Tariffs Bring ‘Turning Point' For Global Trade Of Pharmaceuticals

(4/9, Francesca Bruce, Pink Sheet) ...The Swiss pharmaceutical industry association has called for a UK-style deal to be negotiated with the US for Switzerland...In the longer-term, the tariffs will mean a shift from a globally integrated pharmaceutical supply chain model to more regionalized production systems that are shaped by government policies, the VFA said in a statement... Global Sub. Full

 

US Pharma Tariffs – Exemptions Need More Clarity, Impact Varied

(4/10, Vibha Ravi, Pink Sheet) ...Salil Kallianpur, a former executive vice-president at GlaxoSmithKline in India, told Pink Sheet that though the secretary of commerce has been given discretion to exempt certain specialty drugs "in practice this is likely to be applied selectively."... Global Sub. Full

 

1 Big Thing: Serious Health Care Cost Control Talk

(4/10, Axios) ...The pharmaceutical industry has survived two different administrations' efforts to lower drug prices, and analysts have largely dismissed the changes that were enacted as immaterial to companies' bottom lines...Health care costs have been going up forever. The question has always been whether they'd reach a breaking point - and politically speaking, we might be there... Full

 

US FDA Will Formalize Single-Trial Policy Later This Year, Makary Says

(4/9, Michael McCaughan, Pink Sheet) ..."We are working on the formal guidance process to change the formal guidance from the agency" on expectations for pivotal trials, Makary added. "We are working on internal training by the statistical team here at the FDA. They are very passionate that you can achieve the same statistical power with a well-designed, well controlled, appropriately powered, single pivotal trial, instead of two pivotal trials." Makary also previewed an upcoming announcement for a Real-Time Continuous Trial pilot program that will apparently involve a more direct role for the agency in determining when trials should be stopped for safety issues or because efficacy has been demonstrated... Global Sub. Full

 

FDA Budget Offers Update On Domestic Incentives For Para IV Filings

(4/9, Dave Wallace, Generics Bulletin) ...The proposal would apply to "generic companies based in the US that currently manufacture a generic drug in the US or are making investments in new domestic manufacturing facilities to substantially increase manufacturing capacity of a generic drug in the US," the FDA explained, offering them the chance to file ANDAs and Paragraph IV certifications along current timelines while delaying for a month the date when non-US companies can file their applications... Global Sub. Full

 

Vanda Pharmaceuticals Calls on FDA to Withdraw Proposal from FY 2027 Legislative Agenda That Would Extend Drug Review Timelines

(4/9, Vanda Pharmaceuticals) ..."The FDA's current practice of exceeding the 180-day statutory timeline by issuing Complete Response Letters and operating under longer PDUFA timelines has already been ruled by federal courts to violate the law," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "Instead of complying with the law as written, this proposal asks Congress to change the law so the slower system becomes legal. This is especially concerning because Commissioner Makary said just days ago that the current two-month filing review is too long and should take just days—yet this proposal seeks to codify that very delay into law..."... Full

 

GSK Nixes Application for Drug Touted by Trump for Autism

(4/9, Liz Essley Whyte, The Wall Street Journal) ...Senior FDA officials said they examined scientific studies to see if they could approve leucovorin to treat autism, but didn't come up with enough strong scientific evidence to do so... Sub. Req’d

 

‘The Number One Priority Is Sustainable Access' – AAM Chair Hoffman On Stabilizing The US Industry

Lupin US CCO Discusses 2026 Goals For Industry Association

(4/10, Dave Wallace, Generics Bulletin) ...Speaking with Lupin's US chief commercial officer Bob Hoffman in his new capacity as chair of the Association for Accessible Medicines, the executive is clear on the both the challenges being faced by the US generics and biosimilars industry, and the messages that policymakers need to grasp if the off-patent environment is to remain sustainable... Global Sub. Full

 

FTC Drug Divestiture Policy May Reduce Competition, Study Finds

(4/10, News Medical) ...[N]ew data from UC Berkeley Haas and UC Law shows the FTC's historic remedy-requiring merging companies to divest pipeline drugs to third parties-appears to have backfired. The study, co-authored by Haas Associate Professor Yaniv Konchitchki and Robin Feldman, Gideon Schor, and Tanziuzzaman Sakib of UC Law, looked at 75 pipeline drugs divested over 13 years and found: 81% failed to achieve FDA approval, market entry, and at least a 1% market share... Full

 

Kelly Signs Law Strengthening Oversight, Regulation of Pharmacy Middlemen

(4/9, Morgan Chilson, Kansas Reflector) ...SB 20 gives the Kansas insurance commissioner increased authority to regulate PBMs, mandates drug rebates pass through to health plans, and bans spread pricing so PBMs can no longer charge health plans more than they reimburse pharmacies... Full

 

Novartis Loses Appeal to Halt Mississippi Drug Discount Law

(4/9, Nyah Phengsitthy, Bloomberg Law) ...The company argued the state law is preempted by federal law and dramatically expands the scope of the 340B program. "Novartis failed to show a likelihood of success on the merits of its preemption claim," a three-judge panel said in a six-page opinion. "Because Congress left those matters unaddressed, they remained subject to state regulation," the court added... Sub. Req’d

 

 

Gilead Pays Kymera $45M to Glue Preclinical Protein Degrader onto Burgeoning Oncology Pipeline

(4/9, Nick Paul Taylor, Fierce Biotech) ...Gilead has tucked another drug candidate into a pipeline bulging from a recent deal flurry, paying $45 million to exercise its option on Kymera Therapeutics' preclinical anticancer molecular glue degrader...Kymera is passing the baton to Gilead, which will run IND-enabling studies with the goal of filing to test the drug candidate in humans next year. The planned studies build on preclinical tests that Kymera said showed KT-200 achieves low-nanomolar degradation of CDK2... Full

 

Roche Takes 'Leap of Faith' with $20M Bet on C4T's Antibody-Targeted Protein Degraders

(4/9, Nick Paul Taylor, Fierce Biotech) ...Roche is excited about the potential for DACs to overcome therapeutic window and resistance issues linked to ADC payloads, Barbara Lueckel, Ph.D., the drugmaker's global head of research technologies partnering, told Fierce. DACs kill cancer cells via targeted protein degradation, rather than the broad cytotoxicity of ADCs, and as such could be less likely to cause toxicity or drive drug resistance... Full

 

 

Biocon Launches Held-Back Denosumab Biosimilars In The US

(4/9, Urte Fultinaviciute, Generics Bulletin) ...Shreehas Tambe, Biocon Ltd's CEO, called the US launch "a strategic expansion of our biosimilars portfolio, building on our established leadership in oncology and immunology."..."This milestone underscores Biocon's strength as a portfolio development engine and our focus on building the world's most scalable access platform – advancing life-changing medicines for patients and health systems across the US and around the world," he added... Global Sub. Full

 

‘Eggs Solve All Of Those Problems' – How Neion Bio Is Seeking To Shake Up Biosimilar Manufacturing

(4/9, Dave Wallace, Generics Bulletin) ...As Neion Bio announced its new technology platform to manufacture recombinant biologics in eggs – accompanied by an initial multi-product biosimilar deal – the firm's founders set out their goals in an exclusive interview with Generics Bulletin... Global Sub. Full

 

Generics Remain ‘Critical Foundation' For Arcera

(4/9, Dave Wallace, Generics Bulletin) ...In an exclusive Q&A interview, Isabel Afonso – Arcera's CEO and a former Sandoz executive – talks to Generics Bulletin about how off-patent medicines fit into the firm's wider business model, and how the firm is seeking to expand through "disciplined" M&A and strategic partnerships that will help it expand into new product categories and geographic territories, while also bolstering Abu Dhabi's ambitions to be a global leader in innovative healthcare... Global Sub. Full

 

DifGen Pharmaceuticals LLC, in Collaboration with Apotex Inc., Announces FDA Approval of Generic Nintedanib Soft Gel Capsules, 100 mg and 150mg Therapeutically Equivalent to Ofev®

(4/9, DifGen Pharmaceuticals) ...DifGen Pharmaceuticals...today announced that its partner, Apotex Inc., has received final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Nintedanib Soft Gel Capsules, 100 mg and 150 mg. The approved product is therapeutically equivalent (AB-rated) to the reference listed drug, Ofev®... Full

 

MSN Deal Ends Trulance Dispute, Signals Launch Pathway

(4/9, Dean Rudge, Generics Bulletin) ...MSN Laboratories has brought a five-year US patent dispute over Trulance (plecanatide) to an end after reaching a settlement with Bausch Health and Salix Pharmaceuticals, closing litigation over the once-daily oral therapy approved for adults with chronic idiopathic constipation and irritable bowel syndrome with constipation... Global Sub. Full

 

 

Sun Pharma Preps for $12-Billion Organon Bid in Biggest Overseas Pharma M&A by Indian Co

(4/10, Arijit Barman and Vikas Dandekar, The Economic Times) ...Sun Pharmaceutical Industries has decided to proceed with a binding offer of $12 billion for Organon & Co, taking the company to the final stages of its most ambitious overseas acquisition bid as it looks to become a branded and innovative drug-making powerhouse, said people in the know...At least three global banks were mandated last week to back the bid, which will be the largest global M&A involving an Indian pharma major, if it goes ahead... Full

 

Sanofi Investors Might Have to Wait for Update on Strategy -- Market Talk

(4/10, Dow Jones) ..."Prior management comments suggested the potential for a refocus on the Regeneron [joint venture] for future drug launches but we assume it is too early to explore this potential." Recent drug-pipeline disappointments have made many investors lukewarm on Sanofi, but its steady growth in the near and medium term might attract some, UBS says... Sub. Req’d

 

Eli Lilly Slips, Novo Nordisk Holds Firm as Generic Weight-Loss Drugs Flood India

(4/10, Priyanka Salve, CNBC) ...Eli Lilly's Indian market share in the GLP-1 category of weight-loss drugs fell to 56% in March from 61% a month earlier, according to data from industry intelligence provider Pharmarack. Novo Nordisk's market share remained steady at 25%... Full

 

'It's Going to Be Huge': The 'Diabolical' Molecule Poised to Become Biotech's Next Gold Rush

(4/9, Fierce Biotech) ...Should the Lp(a)-lowering candidates now in the clinic reach their full potential, they could surpass statins—the most prescribed medications in the world—in their use, multiple experts told Fierce Biotech... Full

 

 

Biotech in China is Booming. Big Pharma is Paying Attention.

(4/10, Wall Street Journal) ...China has emerged as a big player in biotechnology, and major drugmakers and investors are catching on. WSJ reporter Peter Loftus tells us how China surged ahead in the biotech race, and why big pharma sees it as an opportunity... Sub. Req’d

 

China Launches Nationwide Plan For AI-Assisted Drug Regulation

(4/10, Xu Hu, Pink Sheet) ...China's top drug regulator, the National Medical Products Administration (NMPA), is grasping a major strategic opportunity provided by the development of artificial intelligence (AI) and is aiming to use the technology as a crucial lever for further reforms and to improve its capabilities in drug regulation, it states in a recent policy announcement... Global Sub. Full

 

Pharma Supply Chains May Take Months to Heal

(4/10, Teena Thacker, The Economic Times) ...The conflict has disrupted shipping routes, resulted in a surge in freight cost and squeezed API imports. Dinesh Dua, former chairman of Pharmexcil, said this could translate into a loss ranging from Rs 2,500 crore to Rs 5,000 crore... Full

 

Korea On Alert For Medical Product Shortages Amid Middle East Crisis

(4/10, Jung Won Shin, Pink Sheet) ...The South Korean government and domestic pharma industry have launched emergency measures to closely monitor medical supply chains and prevent possible shortages caused by the Middle East crisis, in particular naphtha supply disruptions... Global Sub. Full

 

US FDA Seeking To Expand Global Footprint Again With Japan, Vietnam Foreign Offices

(4/9, Derrick Gingery, Pink Sheet) ...Offices are planned for Hanoi, Vietnam, and Tokyo, Japan, the FDA said. The agency's fiscal year 2027 budget request includes a $2.5m increase, as well as five new full-time equivalent employees, to set up the offices... Global Sub. Full

 

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