Friday, September 4, 2026

Teva Price Target Raised to $48 from $42 at UBS

(9/4, The Fly) ...UBS analyst Ashwani Verma raised the firm's price target on Teva to $48 from $42 and keeps a Buy rating on the shares. The firm views the company's Phase 2 success in celiac as an "important milestone."... Sub. Req'd

Teva Pharma (TEVA) PT Raised to $48 at UBS

(9/4, StreetInsider.com) ...The analyst comments "...The immediate stock reaction to positive Ph2 Celiac data has been underwhelming in our view, but this creates meaningful and deep long-term value, which Teva is set to replicate. We continue to view the stock as having a catalyst-rich path into 2027, including potential Russell index inclusion (see prior note), DARI Ph3 data in early 2027, positive TL1A read-across from MRK's updates, and launches of olanzapine LAI and Ecopipam for Tourette's. We believe this favorable setup supports further multiple expansion."... Sub. Req'd

Bipartisan Insulin Price Cap Introduced in House as Lawmakers Seek Affordability Win

(9/3, Nathaniel Weixel, The Hill) ...The Insulin Act — shorthand for the Improving Needed Safeguards for Users of Lifesaving Insulin Now Act — was introduced by Reps. Diana DeGette (D-Colo.), Angie Craig (D-Minn.), Kim Schrier (D-Wash.), Mariannette Miller-Meeks (R-Iowa) and Rob Bresnahan (R-Pa.). It's a companion version of legislation that advanced through the Senate Health Committee earlier this summer... Full

Op-Ed: Rep. Ryan Costello: Congress Has Been Delivering on Healthcare Affordability

(9/3, Rep. Ryan Costello, Washington Reporter) ...Now it's time for Congress to deliver relief to American families by focusing on those who actually drive up drug prices. Voters want lower health care costs. Curbing patent abuse and increasing transparency among wholesalers will deliver that. The road to PBM reform was long and deliberate, but that can't be the end of the drug pricing story... Full

The Unintended Consequences of the DOL PBM Transparency Rule: An Ode to the Little Guy (and Gal)

(9/3, Amanda Frost, PCMA Blog) ...As DOL continues its work considering how to proceed with this rule, I hope it keeps two things in mind. First, the PBM market is comprised of over 70 full-service firms of varying sizes and business models; there are far more small PBMs than there are large ones. And second, the butterfly effect: seemingly small actions can have enormous, far-ranging impacts. A strong, competitive PBM market benefits employers far more than redundant transparency reports do... Full

FTC Backing Could Open New Antitrust Route For Biosimilars

(9/4, Dean Rudge, Generics Bulletin) ...Law firm Crowell & Moring commented that biosimilar developers and health plans may view the FTC's intervention as encouraging because it supports the proposition that an incumbent cannot "simply purchase its way to indefinite exclusivity by acquiring control of pending patent portfolios."... Global Sub. Full

US FDA Expedites Reviews To Ease Estradiol Patch Crunch Its Own Label Change Helped Create

(9/3, Sue Sutter, Pink Sheet) ...In a Sept. 3 notice, the FDA said it is aware of reports that patients are "having difficulty readily accessing their usual estradiol transdermal patches due to increased demand." The agency is working with the six patch manufacturers to increase supply... Global Sub. Full

DOJ Carves Out Narrower Defense Of FDA Civil Penalty Power

(9/3, James Jarvis, Inside Health Policy) ...Just days after Solicitor General D. John Sauer conceded the Department of Justice could no longer defend FDA's in-house civil penalties against tobacco retailers simply by invoking public health or interstate commerce under the Tobacco Control Act, DOJ is now offering a narrower rationale for when those penalties may still be constitutional: when FDA is enforcing "duties owed" to the public as a whole rather than resolving a dispute resembling a traditional private lawsuit... Sub. Req'd

Cipla Announces Exclusive US Partnership with Qilu Pharma for Keytruda Biosimilar

(9/4, Jomy Jos Pullokaran, CNBC TV18) ...Under the agreement, Qilu will be responsible for the development, regulatory registration and supply of QL2107, while Cipla USA Inc. will handle the commercialisation of the product in the defined US territory, leveraging its commercial presence... Full

Samsung Bioepis Gets Japan Nod for Stelara Biosimilar

(9/4, Kim Ji-hye, Korea Biomedical Review) ...The product is approved as induction therapy for patients with moderate-to-severe active Crohn's disease who have had an inadequate response to other treatments. It is the second product approved in Japan under Samsung Bioepis' partnership with Nipro Corporation... Full

Fresenius Kabi Launches Generic Sugammadex in Simplist® Ready-to-Administer Prefilled Syringe in the U.S.

(9/3, Fresenius Kabi) ...Fresenius Kabi...today announced the U.S. launch of the FDA-approved generic Sugammadex Injection. Exclusivity for the branded medicine Bridion® (Merck) expired in July 2026. Fresenius Kabi offers operating room clinicians Sugammadex in a Simplist® ready-to-administer prefilled syringe... Full

Mylan Conflict Challenge Derails September Humana Bellwether

(9/3, Dean Rudge, Generics Bulletin) ...Judge Cynthia Rufe on September 2 granted Mylan's request for a temporary stay of the so-called Humana I action, adjourning that day's scheduled pre-trial conference and staying all outstanding pre-trial deadlines for up to 45 days, or until the court determines otherwise. The September 15 trial will now be rescheduled... Global Sub. Full

GSK Wagers Up to $1.3b on a Different Kind of Cancer Drug

(9/3, Delilah Alvarado, BioPharma DIVE) ...In a deal announced Thursday, GSK agreed to pay Hutchmed $110 million up front, and potentially roughly $1.19 billion more in milestone payments and royalties, for a majority of the rights to a treatment known as HMPL-A830. That treatment is what Hutchmed refers to as an "antibody-targeted therapeutic conjugate," and could potentially address multiple tumor types... Full

Lung Cancer Study That Started Hype for Summit, Akeso's Ivonescimab Hits Survival Goal

(9/3, Matthew Dennis, FirstWord PHARMA) ...Summit and Akeso say the study achieved its key secondary endpoint of OS at a pre-specified interim analysis as well, with ivonescimab demonstrating a statistically significant and clinically meaningful improvement over Keytruda. No specific figures were disclosed, but they are expected to be presented at a future medical conference... Full

AbbVie's Monthly Bispecific Cuts Myeloma Progression Risk by 60%

(9/3, Anna Bratulic, FirstWord PHARMA) ...Overall survival (OS) at 12 months also favoured etentamig at 87.9% versus 72% for the comparator, though AbbVie said the prespecified efficacy boundary for OS had not been crossed at the data cutoff... Full

The Cancer Vaccine Gold Rush Has Begun. So Has the Race for Picks and Shovels.

(9/4, David Wainer, The Wall Street Journal) ...Personalized cancer therapies require a genetic road map for each patient. The tumor has to be sequenced to identify the mutations the vaccine should target. If these therapies become blockbusters, the diagnostic companies doing that sequencing could hold a lucrative tollbooth on every dose... Sub. Req'd

Novartis Puts MS Advocacy on the Podium Through Social Media Partnership with British Olympian

(9/3, Zoey Becker, Fierce Pharma) ...The page is full of resources that can help patients prepare for a doctor's visit, including an MS checklist, a workbook and a questionnaire to help track symptom changes... Full

GoodRx Expands Subscription Offerings with Family Plan for Prescription Meds and Healthcare Services

(9/3, Cailey Gleeson, Fierce Healthcare) ...GoodRx Companion Family Plan covers a primary member and up to four members, with no age restrictions and the inclusion of pets. The plan costs $24.99 per month or $16.99 for members paying annually... Full

ECJ Advocate General's Opinion Proposes to Annul The EPR Cost Allocation Under The EU Wastewater Rules

(9/3, Medicines for Europe) ...Today, the Advocate General, Juliane Kokott, confirmed in her opinion on Poland's challenge before the Court of Justice of the European Union (CJEU – case number C-193/25) serious concerns about the design and proportionality of the extended producer responsibility (EPR) scheme for medicines. As a result, the Advocate General proposes to annul article 9.1 letter a) and Annex III of the Urban Wastewater Treatment Directive (UWWTD) which allocates at least 80% of the costs of the quaternary treatment to the pharmaceutical and cosmetic industry... Full

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