Wednesday, August 12, 2026

 

 

Moody's Upgrades Teva to Investment Grade, Citing Growth and Continued Debt Reduction

(8/12, Ynet) ...Teva Chief Financial Officer Eli Kalif called the Moody's decision "a major milestone" in the company's turnaround. "This recognition, together with Fitch's upgrade in May, reflects years of disciplined execution, continued debt reduction and a stronger financial profile," Kalif said. He added that the higher rating should give Teva greater financial flexibility and access to a wider pool of investors... Full

 

Teva Pharma (TEVA) PT Raised to $42 at Barclays

(8/12, StreetInsider.com) ...Barclays analyst Glen Santangelo raised the price target on Teva Pharma (NYSE: TEVA) to $42.00 (from $40.00) while maintaining a Overweight rating... Sub. Req'd

 

Teva Price Target Raised to $42 from $40 at Barclays

(8/12, The Fly) ...The firm sees potential for further expansion driven primarily by the Teva's pipeline... Sub. Req'd

 

 

Pfizer's Xeljanz And Medicare: A Case Of Market Forces Overtaking Price Negotiation

(8/11, Cathy Kelly, Pink Sheet) ...Pfizer's Xeljanz (tofacitinib) continues to undergo the Medicare price negotiation process even though its upcoming "maximum fair price" will never be implemented because the drug already faces generic competition. The outcome raises questions about whether the government and company should spend the time, effort and money negotiating lower prices in situations where market-based competition likely will produce the same result earlier... Global Sub. Full

 

AARP: MFN Policy Could Add $200 Billion To Projected Medicare Savings

(8/11, Gabrielle Wanneh, Inside Health Policy) ...The findings shed a positive spotlight on the potential for MFN policies -- specifically a policy to base the prices Medicare pays for the 10 most expensive drugs outside of drug price negotiations on the some of the lowest drug prices available to a set of other wealthy countries -- to aid in making medicines more affordable for seniors. However, many consumer groups and drug industry stakeholders remain either confused by or fully opposed to the use of MFN reference pricing policy to lower United States drug prices... Sub. Req'd

 

US Moves Past Tariffs to Focus on Supply Chain Revamps in China Trade Policy

(8/11, Chris Anstey, Bloomberg) ..."We are in the midst of growing drumbeat of US restrictions on Chinese supply chains in critical sectors," Tobin Marcus, head of US policy and politics at Wolfe Research, wrote in a recent note. The main idea is to "crack down on Chinese imports and incentivize onshoring of sensitive products" whenever possible. The administration has "only been pushed off of that position when they've encountered Chinese retaliation or industry warnings about disruptions."... Sub. Req'd

 

Exclusive: Conservative Coalition Backs Legislation From Sen. Tim Sheehy and Rep. Jodey Arrington to Stop European Drug Price Manipulation

(8/12, Matthew Foldi, Washington Reporter) ...Sen. Tim Sheehy's (R., Mont.)..."Use Sovereignty to Reduce Rx Act," or USTRx Act, is designed to fix how European countries have been "freeloading off of our defense and drug industry for years," Sheehy explained to the Reporter. "Germany needs to pay their fair share so we can bring prices down for American consumers." Now, Americans for Health Excellence, the Council for Affordable Health Coverage, No Patient Left Behind, the Association of American Physicians and Surgeons, 60 Plus Association, and AMAC Action are writing to Sheehy and Rep. Jodey Arrington (R., Texas) urging them to keep up the work... Full

 

China Isn't Beating Us — Washington Is Handing Them the Win

(8/11, Ken Blackwell, Washington Examiner) ...Fixing this means acting on three fronts: rebuild domestic manufacturing, protect the incentive to invent here, and stop treating the two as the same problem. The administration has started on the first, ordering a domestically sourced Strategic Active Pharmaceutical Ingredients Reserve and clearing regulatory barriers to producing critical supplies at home. Washington needs to scale that build-out and friend-shore what we should never have let move to adversaries. It also needs predictable regulation and data exclusivity that matches China's, so it's no longer easier to develop a drug in Shenzhen than in Cambridge... Full

 

PhRMA Highlights Need for Germany to Pay Its Fair Share

(8/11, Brian Picone, PhRMA Blog) ...Germany systematically undervalues American innovation by using older medicines and generics as price benchmarks for innovative therapies, disregarding additional clinical benefits of newer medicines and imposing harmful mandatory rebates and price freezes on publicly reimbursed medicines... Full

 

Generic Drug User Fee Agreement Streamlines Meetings, Creates 'Complex Issue' Goal Extension

(8/11, Derrick Gingery, Pink Sheet) ...The new generic drug user fee commitment letter released Aug. 10 streamlines the structure for formal meetings between the US Food and Drug Administration and sponsors. The new format will be implemented Oct. 1, 2027, assuming the program is enacted by Congress and approved by President Trump... Global Sub. Full

 

PIC/S Updates Guideline on Process Qualification and Validation Studies

(8/11, Joanne S. Eglovitch, Regulatory Focus) ...The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has released a revised guide for inspectors and the pharmaceutical industry outlining the general principles of qualification and validation studies in pharmaceutical manufacturing facilities. Its purpose is to guide inspectors and the pharmaceutical industry by promoting medicinal quality assurance through a validation program compliant with good manufacturing practice... Full

 

Acting No More: Sarah Ibrahim Named Permanent CDER Deputy Director

(8/11, Sue Sutter, Pink Sheet) ...Sarah Ibrahim, CDER's acting deputy center director for regulatory programs since January, was given the permanent role, CDER Acting Director Michael Davis announced on Aug. 10... Global Sub. Full

 

340B Pilot Program Could Be Big Boon for Biosimilars

(8/11, Stanton Mehr, Biosimilars Review & Report) ...The objective of any 340B reform is to wrangle an out-of-control pharmaceutical financing program, protect legitimate higher-price sales by the drug industry, and reallocate the program's true benefits back towards safety net institutions. For-profit entities that were squeezing profits from the 340B program can simply purchase lower-cost biosimilars from the outset, and benefit from their deep savings instead... Full

 

Did Exelixis Use a 'Trivial' Modification to its Cash Cow to Product-Hop Past a Patent Cliff? These Researchers Think so

(8/12, John Carroll, Endpoints News) ...Writing in Nature Biotechnology, the authors note that drugmakers trying to execute a "product hop" from a treasured franchise drug to a pricey successor usually focus on new routes of administration or a formulation changeup...In this case, the authors assert that Exelixis made "minor tweaks that offer limited functional innovation to one of its own active pharmaceutical ingredients to execute a product hop, potentially dramatically raising costs for patients and payers." And the company did it by getting a clueless patent office to sign off on it as a new chemical entity... Sub. Req'd

 

US Court Blocks WuXi AppTec's Chinese Military Designation, But Pentagon May Re-File

(8/11, Sue Sutter, Pink Sheet) ...The US Defense Department may designate WuXi AppTec as a Chinese military company, but must bolster its justification for the move, a federal court ruled... Global Sub. Full

 

MD Advocates Push Politicians to Further Limit Drug Prices, as Done With Ozempic

(8/12, Hannah Gaskill, The Daily Record) ...Healthcare advocates are urging politicians to help the Maryland Prescription Drug Affordability Board limit prices for more than two dozen pharmaceuticals. Maryland Health Care for All, a grassroots organization made up of faith, labor, business, professional and community organizations, said it was sending letters Wednesday asking every Maryland General Assembly or gubernatorial candidate to commit to approving a forthcoming bill... Full

 

 

Medincell's Dr Grace Kim to Participate in Piper Sandler CNS Symposium

(8/11, Medincell) ...Medincell (Euronext Paris: MEDCL), a clinical- and commercial-stage innovation-driven biopharmaceutical company developing and licensing long-acting injectable treatments across multiple therapeutic areas, announced today that Dr Grace Kim, Chief Strategy Officer, U.S. Finance, will take part in the annual Piper Sandler CNS Symposium Thursday, August 13, 2026... Full

 

Boulevard Bio Dreams Big in Immunology with $65M, Sights on Vera's IgAN Drug

(8/12, Kyle LaHucik, Endpoints News) ...Boulevard Bio was unveiled Wednesday morning with $65 million in backing from Deerfield Management to advance its three immunology and inflammation (I&I) drug candidates... Sub. Req'd

 

 

Delhi HC Directs Sun Pharma to Take Permission Before Launching Semaglutide

(8/11, Yash Tiwari, Jessica Jani, Mint) ...Justice Anup Bhambani directed Sun Pharma that if and when it receives a commercial manufacturing licence, it must file an application before the court before taking any further steps to launch the drug. The court will then decide whether any further orders are required... Full

 

Celltrion's Xolair Biosimilar Grabs Over 90% of Spain's Omalizumab Market

(8/12, Lee Han-soo, Korea Biomedical Review) ...Celltrion is strengthening its foothold in Spain and Portugal through a string of public tender wins and growing uptake of its newly launched biosimilars, with its Xolair (omalizumab) biosimilar Omlyclo estimated to have captured more than 90 percent of the Spanish omalizumab market as of June... Full

 

 

Aurobindo Claims 5-7 Year Headstart With A1 Biochem, Lannett Acquisitions

(8/12, Vibha Ravi, Generics Bulletin) ...Aurobindo Pharma's 80% stake purchase in contract research unit A1 Biochem in India and buyout of Lannett Co. in the US allow it to leapfrog five to seven years via enhanced US onshoring and R&D capability... Global Sub. Full

 

Cardinal Health Forecasts Full-Year Profit Above Estimates on Specialty Drug Strength

(8/11, Reuters) ...Drug distributors are capitalizing on rising demand for biosimilars and high-margin medicines treating complex conditions such as cancer, rheumatoid arthritis and autoimmune diseases... Full

 

Towa's Core Generics And European Growth Outrun Fresh Sunsho Weakness

(8/12, Dean Rudge, Generics Bulletin) ...Sales for the three months ended June 30 rose by 9.6% to ¥71.4bn ($449m), while operating profit advanced by a quarter to ¥6.5bn. Towa attributed the improvement principally to higher sales volumes and unit prices in its domestic pharmaceutical operations, alongside growth in both business-to-consumer and business-to-business sales in Europe... Global Sub. Full

 

Formycon Reports Higher H1 Revenue, Narrows EBITDA Loss

(8/12, Maria Ponnezhath, Investing.com) ...Formycon's first-half revenue growth was driven by milestone and upfront payments from commercialization and development partnerships for its FYB206 biosimilar... Full

 

Amgen Lays Groundwork for New R&D Center in Hyderabad

(8/11, Darren Incorvaia, Fierce Biotech) ...The new Science and Innovation Center is set to open in Hyderabad's Genome Valley, a biopharma business park, in 2027, an Amgen spokesperson told Fierce in a statement. It will join Amgen's network of R&D sites, the spokesperson said, "which consists of seven research laboratories in the U.S. and abroad." The new center "will bring together scientists and technologists across discovery chemistry, drug metabolism and pharmacokinetics and precision medicine," the spokesperson added... Full

 

 

New EU Tool Helps Drug Developers Check If They Need A Joint Clinical Assessment

(8/11, Neena Brizmohun, Pink Sheet) ...Upon confirming whether their application concerns a marketing authorization or a variation to an existing marketing authorization, users of the tool are directed through a series of branching questions to determine whether their product is subject to a JCA... Global Sub. Full

 

UK MHRA Sets Diversity Goal For 'Western Authority Dominated' PIC/S Pharmacovigilance Group

(8/11, Vibha Sharma, Pink Sheet) ...With the UK's Medicines and Healthcare products Regulatory Agency now chairing the international Pharmaceutical Inspection Co-operation Scheme's (PIC/S) pharmacovigilance expert circle, one of its key priorities is to diversify its membership beyond its current composition of North American and European regulators... Global Sub. Full

 

India Pharma Exports Rise 6.8% to $8.1 Billion in Q1 FY27; Vaccine Shipments Jump 36%

(8/12, The Hindu Businessline) ...Pharmexcil Chairman Namit Joshi said, "India must continue consolidating its leadership in generics while building a stronger presence in complex generics, biosimilars, peptides and other innovation-led segments. "Going forward, Pharmexcil said it will work with the government, industry and overseas stakeholders to strengthen market access and regulatory cooperation and support India's expansion across established and emerging markets... Full

 

Japan Pricing Roundup: Lilly Airs Policy Concerns After Mounjaro Slash

(8/12, Lisa Takagi, Pink Sheet) ...With industry concerns around the potential impact of Japan's regular price cuts on the US's most favored nation price comparison methodology (in which Japan is included in the basket of nations), Eli Lilly's Japanese subsidiary has taken the unusual step of releasing an individual statement arguing against the recent 25% Japanese price cut for its GIP/GLP-1 receptor agonist Mounjaro (tirzepatide) under Market Expansion Repricing rule... Global Sub. Full

 

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