Thursday, November 12, 2026

 

 Top News

 

Teva CEO: We Have Evolved Into a Biopharma Company

(11/12, Shiri Habib-Valdhorn, The Globes) ..."Building on the hard work we've put in at Teva over the last few years, the future looks exceptionally promising. It's a great time to take a fresh look at Teva, whether you're an analyst, an investor, or an employee," Teva Pharmaceutical Industries Ltd. CEO Richard Francis told "Globes" after the company's R&D Day in New York..."...I know some people found it hard to believe this would happen, so we wanted to prove it and demonstrate our robust pipeline, highlight some of our strongest assets, and show people the depth and quality of that pipeline, as well as the commercial capabilities we possess to maximize its potential." He stresses that under this strategy, Teva has come a long way, but this is only the starts... Full

 

Teva CEO Richard Francis Goes One-on-One with Jim Cramer

(11/12, CNBC) ...Teva President and CEO Richard Francis joins 'Mad Money' host Jim Cramer to talk its first R&D day, where it is seeing growth opportunities, its individual offerings, and more... Full

 

Teva Sees Annual Revenue Growth Over Next Several Years on Boost From New Medicines

(11/11, Kelly Cloonan, Dow Jones Newswires) ..."Our R&D engine and commercial excellence are designed to translate proven science into new medicines, with the potential for one new launch annually through 2030," Chief Executive Richard Francis said... Sub. Req'd

 

Teva Pharma Issues Innovative Medicines Revenue Outlook

(11/11, RTT News) ...The company expects mid-single-digit growth in total revenue from 2026 to 2030. Free cash flow target is more than $3.5 billion by 2030... Full

 

Teva Targets $6-7B in Innovative Medicine Revenue by 2030

(11/11, StreetInsider.com) ...Pipeline updates presented include a Phase 2a study of its anti-IL-15 asset in celiac disease that met its primary endpoint, with a Phase 2b study expected to begin in the second half of 2027. The same asset is advancing into a Phase 2/3 study in vitiligo. An investigational anti-PD-1/IL-2 asset called Attenukine is in Phase 1 development for advanced cancer. Teva also highlighted early-stage antibody programs targeting asthma and inflammatory bowel disease... Sub. Req'd

 

Teva Outlines Aggressive R&D Strategy with $7 Billion in Innovative Medicine Revenue by 2030

(11/11, Vandana Singh, Benzinga) ...The company recently launched WELTRUZA, pushing innovative medicines to over 20% of total revenue. Simultaneously, the generics segment stabilized, biosimilar revenue is forecast to double between 2024 and 2026, and the company generated over $6 billion in free cash flow from 2023 to 2025... Full

 

Teva Outlines 2030 Targets Ahead of R&D Day Event

(11/11, Dulan Lokuwithana, Seeking Alpha) ...The Israeli drugmaker added that it targets one innovative medicine launch per year over the next five years, and its key innovative products Austedo, Ajovy, and Uzedy are expected to grow by more than ~125% by the end of this year... Full

 

Teva Targets $6-7 Billion Innovative Medicines Revenue by 2030 at First R&D Day

(11/11, The Pharma Letter) ...Chief executive Richard Francis said innovative medicines revenue has more than doubled since Teva launched its Pivot to Growth strategy in 2023... Sub. Req'd

 

Teva's Celiac Drug Becomes First to Block Gluten Damage in Clinical Trial

(11/11, Alfredo Hanson, Tech Times) ...TEV-'408 drew the most scientific attention at the R&D Day, but Teva's most imminent regulatory event is the pending FDA action on ecopipam, a selective dopamine D1 receptor antagonist for pediatric Tourette syndrome, with a PDUFA target date in late Q1 2027... Full

 

H.C. Wainwright Reiterates Buy Rating on Teva Pharma (TEVA)

(11/12, StreetInsider.com) ...H.C. Wainwright analyst Douglas Tsao reiterated a Buy rating and $54.00 price target on Teva Pharma. The analyst commented: "...The highlight of the presentation was management's outlook for more than $10B in non-risk-adjusted pipeline peak-sales potential and $6-7B in innovative revenue by 2030, supported by an anticipated cadence of at least one product launch annually through the end of the decade..."... Sub. Req'd

 

Teva Price Target Raised to $56 from $44 at Piper Sandler

(11/12, The Fly) ...What has become clear to Piper is that Teva has a drug discovery/development engine, largely immunology-focused, that positions the company for a wave of new launches not only over the next few years but well into the 2030s... Sub. Req'd

 

 U.S. Policy & Regulatory News

 

Dems Unite Against Corporate Health Care

(11/12, Caitlin Owens, Axios) ...While expanding Medicare, reversing GOP Medicaid cuts and reviving enhanced Obamacare subsidies are getting most of the attention, there's a subtle shift in rhetoric and policy positions toward blaming big health companies for the affordability crisis... Full

 

Sen. Rand Paul Makes Bid For HELP Ranking Member

(11/11, Lauren Brensel, Inside Health Policy) ...Sen. Rand Paul (R-KY) is interested in becoming the next top Republican on the Senate health committee, he announced Wednesday (Nov. 11) -- a role he's likely to earn if Sen. Lisa Murkowski (R-AK) claims the top GOP spot on the Appropriations Committee, which would set up Paul, a skeptic of vaccine requirements and government health care programs, as a fierce opponent to incoming chair Sen. Bernie Sanders (I-VT)... Sub. Req'd

 

State Scrutiny of PBMs Is Far From Over

(11/11, Will May, PhRMA Blog) ...As policymakers continue searching for affordability solutions, the question is no longer whether PBMs deserve scrutiny. Recent reforms represent meaningful progress. Now, the focus should be on ensuring those reforms work as intended and that oversight keeps pace as insurer and PBM business models evolve... Full

 

Will PBM Rebate Reform Help Biosimilars Win Formulary Spots?

(11/11, Sabrina McCrear, The Center for Biosimilars) ...Rebate pass-through and transparency are only one step toward supporting biosimilar uptake, and employers should watch for what replaces rebates, Juliana M. Reed, MS, executive director of the Biosimilars Forum, said in an interview with The Center for Biosimilars. "I think what we have to watch for-and this is where it's important for employers to require transparency-is what replaces rebates," she said. "Are there new fees? Are there new things that the PBM can implement to continue to have the same amount of revenues coming in because they control access?"... Full

 

Exclusive-US FDA Shelves Commissioner's Voucher Program for Speedy Drug Reviews, Sources Say

(11/12, Reuters) ...Once touted as a bold fix for US pharmaceutical regulation, the program has been left adrift, offering a stark window into the internal chaos, infighting, and lack of steady leadership that have plagued the FDA, which has been without a commissioner since May... Full

 

BIO Calls For White House Biotech Office, FDA Reforms To Strengthen U.S. Competitiveness

(11/11, James Jarvis, Inside Health Policy) ...In a new seven-point proposal released Tuesday (Nov. 10), BIO outlined several policy recommendations intended to accelerate drug development, expand access to clinical trials and make the United States more competitive in biomedical research and manufacturing. They include calling for the establishment of a White House biotechnology office and for FDA reforms aimed at better assessment of innovative products... Sub. Req'd

 

The FDA Has Over 1K Open Jobs — and The Staffing Shortage Is Hitting Pharma

(11/11, Kelly Bilodeau, PharmaVoice) ...As FDA works to stabilize staffing levels, pharma companies should be more careful when preparing submissions and engaging with the FDA, [Nathan Downing, a managing attorney at Gardner Law,] said. FDA is increasingly using AI to augment human reviews, so materials should be presented in a way that is easy for the technology to digest, according to Downing. Key data needs to stand out, because human reviewers sometimes send requests for data that's already in the paperwork... Full

 

US FDA's Inspection Decisions Now May Hinge On Remote Assessments, Foreign Reports

(11/11, Manas Mishra, Pink Sheet) ...A new Concept of Operations (ConOps) 2.0 for drug facility inspections, an agreement between the Center for Drug Evaluation and Research and the Office of Inspections and Investigations, adds remote regulatory assessments (RRAs) and mutual recognition agreement (MRA) inspection reports as evaluation tools... Global Sub. Full

 

What to Know About The Shortage of Estrogen Patches for Menopause Relief

(11/11, Sammy Westfall, The Washington Post) ...The shortage has significantly impacted women's ability to fill prescriptions for the patches, Kathleen Jordan, chief medical officer of virtual health care platform Midi Health, said in a statement to The Washington Post...Jordan, of Midi Health, said she expects that demand will "only continue to grow" as women gain access to more information about menopause care... Full

 

 Generics & Biosimilars News

 

Zydus Doubles Down On High-Value Pivot; Adempas, Ibrance Generics To Add Fuel

(11/12, Vibha Ravi, Generics Bulletin) ..."We are making significant progress in reshaping our US business beyond generics and towards a higher-value specialty and biologics portfolio. Our differentiated 505(b)(2) products, rare disease offerings and the biologics pipeline are creating powerful new growth vectors," said Zydus managing director Sharvil Patel during the company's call regarding Q2 FY27, which ended Sept. 30... Global Sub. Full

 

Lupin Launches Biosimilar Ranibizumab in European Market

(11/12, Express Pharma) ...Thierry Volle, President EMEA and Emerging Markets, Lupin, said, "The launch of Ranluspec in Europe advances Lupin's strategy of bringing high-quality biosimilars to more patients suffering from retinal and choroidal vascular diseases. Together with Sandoz, we will expand access to this important treatment across the region."... Full

 

Lupin Doubles Down On US Growth As Competition To Key Generic Assets Dents Q2

(11/10, Urte Fultinaviciute, Generics Bulletin) ...Lupin's US business is navigating "an evolving competitive environment," said CEO Vinita Gupta, as the firm is bracing for the end of market exclusivity for its key generic assets – tolvaptan and mirabegron... Global Sub. Full

 

Celltrion Seeks Australian Approval for Cosentyx Biosimilar

(11/12, Park Woo-in, Seoul Economic Daily) ...The company said on the 12th that it had filed for product approval with Australia's Therapeutic Goods Administration (TGA). Visecuma is a biosimilar of Cosentyx, which inhibits interleukin (IL)-17A, a substance involved in inflammatory responses... Full

 

'We Want Partners Who Can Grow With Us' – CinnaGen Chair Hamedifar On The Firm's Plans For Europe

(11/12, Dave Wallace, Generics Bulletin) ...In an exclusive Q&A interview with Generics Bulletin, CinnaGen group chairperson Haleh Hamedifar talks about the early significance of the firm's CinnoVex and ReciGen interferon beta-1a products in 2006 and 2008, detailing how they "gave our people confidence that we could do what many believed was not possible from our region."... Global Sub. Full

 

 Industry News

 

Germany's Merck Raises Guidance Again on Growth Across Units

(11/12, Adrià Calatayud, The Wall Street Journal) ...The company said Thursday that its latest guidance increase—which follows earlier upgrades alongside its earnings for the first and second quarters—reflected improvements in its underlying performance as well as favorable currency movements, and attributed its third-quarter results to the strength of its integrated business model... Sub. Req'd

 

Apotex Delivers Strong Second Quarter 2027 Results and Raises FY2027 Guidance

(11/12, Apotex Health Corp.) ..."Apotex delivered a strong second quarter, with revenue growth accelerating to 5% and Adjusted EBITDA increasing 19%. Our launch engine continues to perform well, with approximately 60 launches year to date, 70% of which were first to market. Disciplined execution, productivity initiatives and a stronger portfolio mix contributed to another quarter of profitable growth, reinforcing our confidence in the business and the opportunities ahead," stated Jeff Watson, President and CEO... Full

 

Pfizer Signs $1.5 Billion Deal With Blackstone to Fund Weight-Loss-Drug Development

(11/11, Katherine Hamilton, The Wall Street Journal) ...In exchange for the funding, Blackstone would be eligible to receive milestone-based payments, the companies said Wednesday. Pfizer still needs U.S. regulatory approval of the drug to achieve the commercial sales milestones... Sub. Req'd

 

Fresenius Sells €524 Million Stake in Dialysis Company

(11/12, Sonja Wind, Bloomberg) ...Chief Executive Officer Michael Sen said the funds raised will give Fresenius further capacity to redeploy capital into growth platforms including biosimilar drugs, medical technology and nutrition. It also allows Fresenius the "strategic flexibility to act on the opportunities in front of us," he said... Sub. Req'd

 

Alembic Bets on 30 New US Launches to Retain 40% Growth as Bosutinib; Exclusivity Ends

(11/12, Anjali Singh, Business Standard) ...The US formulations business of the Vadodara-based drugmaker grew 77 per cent in the September quarter. The base business grew 23 per cent and new launches accounted for the rest. Bosutinib, an oncology drug, was a "standout contributor" but its exclusivity ends this month... Full

 

Feds Arrest Top Official of Healthcare Company, Alleging Illegal Drug Importation

(11/11, Scott Zamost, CNBC) ...John Thomas Howard, treasurer and a director of the company, CANARX, was arrested Sunday on smuggling and conspiracy charges, according to the records. Bob Howard, his brother, who is president and a director of CANARX, is also wanted in the federal investigation, according to an affidavit from Dustin Dobbs, a special agent with the Food and Drug Administration's Office of Criminal Investigations. He has not yet been taken into custody... Full

 

Could We See 10 Chinese Big Pharmas Within a Decade? Some CEOs Think So

(11/11, Leslie Zhen Liang, Fierce Pharma) ...For executives at many of the Chinese drug developers who spoke to Fierce, the real prize is a seat at the Big Pharma table. In recent years, this objective has moved from a vague aspiration to a concrete goal... Full

 

 International News

 

India's Push for More Reliable Drug Manufacturing

(11/12, The Pharma Letter) ...For India's manufacturers, the developments to watch now include any formal implementation of the July announcement, alongside sustained factory compliance and commercial output from supported ingredient projects. These will help determine both the reliability of Indian production and the conditions under which its medicines reach overseas customers... Sub. Req'd

 

Korea Regulator Plans New Up To Six-Fold Fee Hikes To Meet Costs

(11/12, Ryner Lai, Pink Sheet) ...The ministry said the revisions are intended to bring regulatory fees more closely in line with the actual costs of reviewing applications. According to the MFDS, clinical, statistical and quality data submitted for drug authorizations have become increasingly complex as filings incorporate newer technologies, raising the difficulty of its regulatory assessments and increasing the need for reviewers with specialist expertise... Global Sub. Full

 

Korean Generic Exclusivity Sparks Patent Disputes Without Expanding Market Entry

(11/11, Bioengineer.org) ...An empirical analysis of pharmaceutical regulatory data in South Korea reveals that legal mechanisms designed to accelerate generic competition have generated an influx of patent challenges without reliably increasing the number of generic competitors reaching the market... Full

 

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