Tuesday, July 21, 2026

 

 Top News

 

Piper Sandler Reiterates Overweight Rating on Teva Pharma (TEVA)

(7/21, StreetInsider.com) ...Piper Sandler analyst David Amsellem reiterated an Overweight rating and $42.00 price target on Teva Pharma...The analyst commented: "We co-hosted a webinar featuring a leading dermatologist who manages a sizable number of patients with vitiligo (and leads a large academic-based practice). The commentary on Teva's IL-15-directed antibody TEV-'408 was favorable (refer to our note on 7/7/26 for more details on the recently announced Phase Ib results for TEV-'408 in non-segmental vitiligo (NSV)). Put differently, the mechanistic rationale here is sound... Sub. Req'd

 

 U.S. Policy & Regulatory News

 

Makers of Rare Disease Drugs Seek Exemption From Trump's Price-Cut Pilots

(7/21, John Wilkerson, STAT+) ...The coalition's prospects of success are uncertain, but it wouldn't be the first time industry convinced the government to make exceptions for orphan therapies... Sub. Req'd

 

The U.S.-China Biotech Race Has Begun

(7/20, Gary Andres, RealClearHealth) ...Clinical trials rarely make headlines, but they are the invisible infrastructure of biomedical leadership. Wherever trials go, investment, talent, and innovation tend to follow. Recognizing the need to protect this critical asset, the Trump administration is also seeking the support of Congress to codify these trial reforms into law. Next year's user fee reauthorization offers policymakers across the Executive Branch and Capitol Hill, a unique opportunity to take this important step. HHS looks forward to working with the Congress to execute this objective... Full

 

CSRxP Encourages U.S. House Energy & Commerce Committee to Advance Bipartisan Solutions to Promote Biosimilar Competition, Lower Drug Prices

(7/20, The Campaign for Sustainable Rx Pricing) ..."Promoting greater biosimilar competition to Big Pharma's high-priced biologic brand name drugs is critical to effectively lower prescription drug prices for American consumers," said CSRxP executive director Lauren Aronson. "Unnecessary regulatory barriers continue to delay biosimilar competition and make it easier for Big Pharma to maintain and extend monopoly pricing on blockbuster products, keeping Americans locked into paying high prices."... Full

 

PCMA on E&C Committee Markup: With PBM Transparency Already Law, Time to Shine Light on Other Areas of the Supply Chain

(7/20, PCMA) ...David Marin, President and CEO of PCMA, issued the following statement in advance of the markup: "For years, the narrative in Congress was that PBMs need more transparency. That narrative is now out of date because Congress passed unprecedented PBM transparency into law this year. PBMs will be required to show employers how they are compensated as well as drug-by-drug, claim-by-claim data. In addition, easily accessible information about prescription options and costs is available to doctors and patients through real-time benefit tools that PBMs offer, providing transparency at the time of prescribing."... Full

 

Tucked in The State Budget, a Win for Pharmacies Looking for PBM Regulation

(7/20, Ian Karbal, Pennsylvania Capital-Star) ...The new provision will require pharmacy benefit managers, or PBMs, to allow pharmacies that they previously ended contracts with to reapply to their networks after 12 months, assuming they're in good standing with state and federal laws... Full

 

Claims Open To Dip In The $533m Settlement Pot From US Price-Fixing Saga

(7/20, Urte Fultinaviciute, Generics Bulletin) ...Companies that settled denied any wrongdoing. In the meantime, the lawsuit remains ongoing against the non-settling defendants. The court granted final approval for settlements from Apotex and Heritage, Sandoz, Sun Pharma and its subsidiary Taro... Global Sub. Full

 

Judge Tosses Vanda's Fight Against FDA's Drug Approval Structure

(7/20, Nyah Phengsitthy, Bloomberg Law) ..."Though this court arguably had jurisdiction to resolve the parties' dispute at first, it no longer does," Judge Amit Mehta for the US District Court for the District of Columbia Circuit said in an order filed July 17. "Vanda has raised the same Appointments Clause arguments made here in the D.C. Circuit," Mehta added. "A favorable ruling on that question would have precedential effect, rendering this court's relief inconsequential."... Full

 

 Generics & Biosimilars News

 

Aspen Pharmacare Wins Canada Approval for Generic Ozempic After Novo Patent Expiry

(7/20, Nqobile Dludla, Reuters) ...Aspen Pharmacare said on Monday that its Canadian subsidiary had received regulatory approval from Health Canada for Aspen-Semaglutide, a generic version of Novo Nordisk's blockbuster diabetes drug Ozempic...The timing of Aspen's commercial launch in Canada remains dependent on the availability of semaglutide active pharmaceutical ingredient (API) supply from India's Dr. Reddy's Laboratories, the company said... Full

 

Truxima Keeps Top U.S. Biosimilar Share

(7/21, Choi Mun-hee, BusinessKorea) ...According to pharmaceutical market research firm IQVIA, Truxima posted a 38.6% market share in the U.S. market in May. That was up 2.8 percentage points from February, when it first rose to No. 1, widening the gap further with competitors including the originator product... Full

 

FDA Grants Tentative Approval to Generic Olaparib Tablets

(7/20, Oncology Nursing News) ...The U.S. Food and Drug Administration (FDA) has granted tentative approval to NATCO Pharma Limited for its generic olaparib tablets in 100-mg and 150-mg strengths, according to a press release issued by the manufacturer... Full

 

Real-World Natalizumab Biosimilar Switch Reduced Treatment Satisfaction Despite Stable Outcomes

(7/20, Brooke McCormick, The Center for Biosimilars) ...In the real-world cohort study published in Multiple Sclerosis and Related Disorders, researchers at Amsterdam UMC followed 83 patients with RRMS who were switched from originator natalizumab to the first FDA-approved MS biosimilar as part of a hospitalwide, cost-driven conversion... Full

 

 Industry News

 

Novartis Returns to Growth on Sales Momentum From Key Drugs

(7/21, Adrià Calatayud, The Wall Street Journal) ...Net sales for the second quarter were $14.41 billion, up 1% at constant currency, the Swiss drugmaker said Tuesday. Growth from some of its top-selling products, such as cancer drugs Kisqali and Pluvicto, and multiple-sclerosis treatment Kesimpta, offset declines for medicines that lost patent protection... Sub. Req'd

 

Big Pharma's Big Brand: Novartis Reconnects to its Past as it Moves Forward

(7/20, Ben Adams, Fierce Pharma) ...Now, to help celebrate its 30th anniversary, Novartis is tapping the colors, culture and successes of its past to help create a brand evolution that guides its future... Full

 

Granules India's First-Quarter Profit Surges as Margins Improve

(7/21, Reuters) ...Granules India reported a nearly 60% rise in first-quarter profit on Tuesday as margins improved in its complex generics business... Full

 

Lupin Takes 82.2% Stake in Kaveri Therapeutics, Licences 2 Oncology Assets for $1.6mn

(7/21, The Hindu) ...Lupin Inc (LI), which has entered into a licensing arrangement with Kaveri to grant exclusive perpetual license for two of its oncology programmes -- LNP7457 (PRMT5) and LNP8701 (SOS1) -- will provide seed funding to Kaveri. LI has received 332,000 common shares (82.2% equity stake) in Kaveri, in exchange of license, the company said in its regulatory filing... Full

 

Biotech Deals Surge to Record as Fear of Missing Out Grips Big Pharma

(7/21, Aanu Adeoye, Oliver Barnes, Financial Times) ...Executives and bankers say the most powerful catalyst for the deal fever is what is known as the "patent cliff", a recurring feature of the industry in which drugmakers lose the exclusivity on prized medicines, paving the way for generic manufacturers to sweep in and produce cheaper versions. The cut-throat hunt for experimental drugs with the potential to become the next generation of blockbusters means the pharma industry stands out even amid the wider global boom in mergers and acquisitions this year... Sub. Req'd

 

BMS Again Turns to NVIDIA to Ramp Up AI Compute for Drug Discovery

(7/20, Anna Bratulic, FirstWord PHARMA) ...The new agreement will see BMS deploy the tech giant's DGX Vera Rubin NVL72 systems, creating what BMS calls the most powerful single-owned NVIDIA computing infrastructure in the life sciences. It says it plans on using that firepower to advance its increasingly sophisticated AI-driven programmes across oncology, haematology, cardiovascular disease, immunology and neuroscience... Full

 

Investors Bet on AI Drug Discovery Despite Approval Gap

(7/21, Patrick Temple-West, Cristina Criddle, Financial Times) ...The rush of investment comes as large pharmaceutical companies including Eli Lilly and AstraZeneca have struck partnerships with AI companies to help identify new medicines. Around 850 AI-developed drugs are in progress globally, according to UBS, but none has yet won regulatory approval in the US... Sub. Req'd

 

Active US Drug Shortages Rise for Third Straight Quarter

(7/20, Maggie L. Shaw, AJMC) ...Health care practitioners have described these recurring generic sterile injectable (GSI) shortages as primarily rooted in the business and quality-control decisions that manufacturers make when profit margins on decades-old generics shrink toward zero... Full

 

 Israel News

 

Merck Downsizing Two Israeli Development Centers

(7/19, Gali Weinreb, Globes) ...Merck said, "Merck is committed to Israel and will remain here. We are downsizing in some areas, as part of a global strategic shift, and intend to expand activity in some other areas, in order to be more customer-oriented and better utilize the advantages of the Israeli ecosystem, in all three of our areas of activity - life sciences, biotech and electronics."... Full

 

 International News

 

Canadian Generics Face Tougher Path Around Dosing Regimen Patents

(7/21, Dean Rudge, Generics Bulletin) ...In a judgment issued July 17, Canada's top court dismissed Pharmascience's appeal and confirmed that Janssen's Canadian patent 2,655,335 claims patent-eligible subject matter under the country's Patent Act, without awarding costs to either party. The ruling leaves intact earlier decisions by the country's Federal Court and Federal Court of Appeal rejecting Pharmascience's argument that the patent improperly monopolizes a method of medical treatment... Global Sub. Full

 

SPC Extension Or Not, Europe Must Prove It Can Deliver Returns

(7/20, Eliza Slawther, Pink Sheet) ...A European Commission proposal that could see some innovative drugs given a 12-month supplementary protection certificate (SPC) extension has proven a highly controversial element of the upcoming Biotech Act. A leading generics industry figure has called for it to be "eliminated," while those representing the research-based sector claim the proposal does not go far enough to incentivize investment in Europe's struggling biotech industry... Global Sub. Full

 

'No Longer Unilateral': EMA Prepares For 'New Normal' On EU Drug Filing Dates

(7/20, Vibha Sharma, Pink Sheet) ...Participation in the initiative will be voluntary for companies and rapporteurs, and the pilot will be open to all types of MAAs, the EMA's Francesca Day told the Pink Sheet in an interview. "We would like companies to have this sort of gentleman's agreement" that "they will agree in good faith the submission date together," said Day, head of the EMA's Therapeutic Areas Department... Global Sub. Full

 

Study: China Outpaces the US in Cancer Approvals, Lags Behind on First Approvals

(7/20, Joanne S. Eglovitch, Regulatory Focus) ...While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more first-in-class drugs and tended to approved products faster and earlier than China, according to a recent study published in Health Affairs... Full

 

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