Thursday, November 5, 2026

 

 

Teva Builds On Samsung Bioepis Alliance With Another Two Products As Biosimilars Exceed Expectations

(11/4, Dave Wallace, Generics Bulletin) ..."This agreement strengthens our collaboration with Samsung Bioepis and will expand our US immunology portfolio with two additional biologic treatment options," commented Teva president and CEO Richard Francis, who underlined that biosimilars "are an important part of our Pivot to Growth strategy, helping us build a stronger portfolio while expanding access to high-quality medicines." His counterpart at Samsung Bioepis, Kyung-Ah Kim, said the firm was "delighted to expand our strategic alliance with Teva to strengthen the commercial footprint of our immunology portfolio in the US."... Global Sub. Full

 

MindWalk Signs Multi-Year AI Deal with Teva Australia

(11/4, StreetInsider.com) ...Under the agreement, Teva Australia will use the AI capabilities to support discovery decisions based on generated predictions and to accelerate antibody design optimization. Deployment and use will be subject to Teva Australia's information-security, privacy, data-governance, scientific-review, and human-oversight requirements. Financial terms were not disclosed... Sub. Req'd

 

How Teva Selects AI for 30 Factories

(11/4, IIoT World) ...At the Industrial AI Summit 2026, Maya Schushan-Orgad of Teva Pharmaceuticals explained how the company's Teva Rise program selects, tests, and scales AI across a regulated pharmaceutical manufacturing network... Full

 

Bulgaria's Spending on Generic Medicines Drastically Below EU Average

(11/4, Krassen Nikolov, Rapporteur) ...The industry sees this as a missed chance to contain rising healthcare costs and widen patients' access to treatment without out-of-pocket payments. "There is room for improvement when it comes to investment in generic medicines," Nikolay Hadzhidontchev, chief executive of Teva Bulgaria and chairman of BGPharmA, told a conference in Sofia. He said the share of generic and biosimilar medicines in public pharmaceutical spending should rise significantly in the coming years... Full

 

Teva Pharma (TEVA) PT Raised to $57 at TD Cowen

(11/4, StreetInsider.com) ...TD Cowen analyst Joseph Thome raised the price target on Teva Pharma (NYSE: TEVA) to $57.00 (from $55.00) while maintaining a Buy rating... Sub. Req'd

 

Teva Price Target Raised to $57 from $55 at TD Cowen

(11/4, The Fly) ...The firm said Teva announced earnings featuring a top line beat backed by performance of the innovative product portfolio including Austedo, Uzedy, and Ajovy... Sub. Req'd

 

 

Debt Limit, Tariffs Top List of Likely Deals in Trump's New Era

(11/4, Erik Wasson, Ari Natter and Yash Roy, Bloomberg) ...Among the areas ripe for compromise in next year's Congress are abolishing the debt ceiling, raising defense and domestic agency spending, renewing Obamacare subsides, capping drug prices and lowering inflation-spiking tariffs through a series of new trade deals... Sub. Req'd

 

Democrats' Big Challenge on Health Care Costs

(11/5, Caitlin Owens, Axios) ...Their unexpectedly large majorities in each chamber will give them leverage, but no guarantee of a victory, if there's a standoff with Trump... Full

 

Pharma Critic Bernie Sanders Is Set to Hold Major Sway Over FDA Funding Bill

(11/4, Margaret Manto, STAT+) ..."Senator Sanders has, over the years, been one of the most effective critics of the excesses of the pharmaceutical industry," said Jerry Avorn, a professor at Harvard Medical School who has written several books about the FDA's regulation of prescription drugs. "In that sense, I think we can look to a much tougher negotiating stance on the part of his committee vis-à-vis the industry in what happens with PDUFA."... Sub. Req'd

 

Education And Finding New 'Champions': How The US Midterms Will Reshape Off-Patent Lobbying Efforts

(11/5, Dave Wallace, Generics Bulletin) ...Speaking to Generics Bulletin after the US midterm elections, AAM chief executive John Murphy III says the new political landscape will require fresh education efforts and building "champions" to work with on affordability and access to medicines, as GDUFA and BsUFA reauthorizations loom... Global Sub. Full

 

US FDA Acting Chief Of Staff Sees Stable User Fee Path Despite Democrats' Capitol Hill Takeover

(11/4, Maaisha Osman, Pink Sheet) ...US Food and Drug Administration Acting Chief of Staff Lowell Zeta said the agency expects continued bipartisan support for its upcoming user fee reauthorization in the wake of the midterm elections..."I think the assumptions remain," he said. "There's been really great bipartisan support for the [user fee] programs."..."We feel confident and stand behind them," Zeta said... Global Sub. Full

 

FDA Official Urges Sponsors to Use Alternatives to Clinical Efficacy Studies for Biosimilars

(11/4, Joanne S. Eglovith, Regulatory Focus) ...Sarah Yim, director of the US Food and Drug Administration's (FDA) Office of Therapeutic Biologics and Biosimilars in the Office of New Drugs, emphasized that the agency is actively working to help sponsors reduce their reliance on clinical efficacy studies to demonstrate that a new biosimilar is comparable to its reference drug and to build public confidence in biosimilars... Full

 

 

AbbVie Pens $1.4B Deal for Deprioritized IBD Drug from Nxera

(11/4, James Waldron, Fierce Biotech) ...AbbVie has added another angle to its relationship with Nxera, with the Big Pharma paying $100 million upfront for a phase 1 inflammatory bowel disease (IBD) candidate. In exchange for the worldwide rights to develop the oral EP4 receptor agonist, dubbed NXE0033744, in IBD, AbbVie is also liable to pay up to $1.37 billion in development and commercial milestones, as well as tiered royalties should the candidate make it to market... Full

 

 

Indian Drugmaker Dr Reddy's Gets Brazil Regulator Nod to Sell Generic Ozempic

(11/5, Reuters) ...The country's National Health Surveillance Agency (ANVISA)authorised generic semaglutide to treat adults with insufficiently controlled type 2 diabetes mellitus, alongside diet and exercise... Full

 

FDA Tentative Approval Clears Path For Dr Reddy's Launch Of Generic Lenacapavir In 120 Countries

(11/4, Urte Fultinaviciute, Generics Bulletin) ...First supplies of the twice-yearly injectable for HIV prevention are expected to reach countries included in the originator Gilead's voluntary license before the end of 2026. Broader access rollout across eligible countries is expected next year... Global Sub. Full

 

 

AstraZeneca Made $10 Billion Offer for Rhythm Pharmaceuticals

(11/4, Lauren Thomas and Xavier Martinez, The Wall Street Journal) ...AstraZeneca recently made a roughly $10 billion offer to buy Rhythm Pharmaceuticals, according to people familiar with the matter, a deal that would expand its portfolio of rare disease treatments. The U.K. pharmaceutical giant offered to pay $124 a share for the biotech last month, the people said... Sub. Req'd

 

Viatris Reports Third-Quarter 2026 Financial Results

(11/5, Viatris) ..."Momentum across key areas of our base business, progress in our pipeline and the benefits of our enterprise-wide strategic review continue to strengthen our company. With the recent U.S. launch of Gwyn Lo, approvals of RYZUMVI in the U.S. and WAKIX in Japan, the potential upcoming approval and launch of fast-acting meloxicam and our recently announced agreement to acquire Pacira BioSciences, we are taking important steps to position Viatris for sustained revenue and earnings growth."... Full

 

ANI Pharmaceuticals Reports Third Quarter 2026 Financial Results

(11/5, ANI Pharmaceuticals) ..."As we head into the end of the year, we are focused on delivering our 2026 financial guidance and advancing the proposed acquisition of Egetis toward closing. We are also executing multiple operational and strategic initiatives to achieve approximately 40% year-over-year growth in 2026 for Cortrophin and capture the significant multi-year growth opportunity ahead," [Nikhil Lalwani, President and CEO of ANI,] concluded... Full

 

India's Aurobindo Pharma's Quarterly Profit Rises by a Third on Strong US Demand

(11/5, Reuters) ...Aurobindo Pharma reported a nearly 33% rise in second-quarter profit on Wednesday, led by strong demand and volume gains in its US market...The drugmaker benefited from the acquisition of generic pharmaceutical company Lannett and an injectables ramp-up in the US market... Full

 

Hikma Falls as Injectables Outlook Cut Despite Strong Guidance for Branded Unit

(11/5, Iain Gilbert, Sharecast) ...Hikma now expects injectables revenue to be broadly flat in 2026, compared with previous guidance for low single-digit growth, although it maintained expectations for a core operating margin of 27% to 28%... Full

 

Pharma CEOs Skeptical Of AI as Cure-All

(11/5, Xavier Martinez, The Wall Street Journal) ...Pharma executives don't buy it. "That's complete BS," said Jeff Leiden , executive chairman of Vertex Pharmaceuticals , recalling a recent conversation with a tech leader who claimed AI would cure 90% of human disease in the next seven years..."It just doesn't work by itself," Leiden said, "and any company that says they can do that -- at least in our experience, we've looked at most of them -- it's not true."... Sub. Req'd

 

 

EMA Considers Faster Route For Smaller Drug Development Questions

(11/4, Dean Rudge, Pink Sheet) ...Bruno Sepodes, chair of the EMA's human medicines committee, the CHMP, said he had taken note of calls for an "expedited route" for smaller questions that currently go through formal scientific advice. "We need something more agile," Sepodes said during the annual symposium of The Organisation for Professionals in Regulatory Affairs (TOPRA), held in Utrecht, the Netherlands, on Oct. 19-21. "I think we all understand that need and again, it's being considered," he added... Global Sub. Full

 

Russia Is Still Hooked on Western Companies for Vital Medicines

(11/5, Tony Halpin, Bloomberg) ...That dependency on the West isn't likely to disappear anytime soon, according to Yaroslav Kabakov, strategy director at Finam Investment Company in Moscow. "Import substitution remains a key driver for Russian pharma, but its potential is limited," Kabakov said. "The transition to true technological independence requires serious investment, proprietary R&D and time."... Sub. Req'd

 

Govt Proposes Immediate Licence Suspension for Substandard Drugmakers

(11/5, Sanket Koul, Business Standard) ...The Union Health Ministry is weighing the immediate suspension of manufacturing licences for medicines that fail critical quality tests to curtail the distribution of unsafe drugs through market channels while regulatory proceedings are underway against non-compliant drugmakers... Full

 

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