PMV Aims For Q1 2027 Filing With Rezatapopt For Second-Line+ Ovarian Cancer
Targeting patients with the TP53 Y220C mutation, thought to be present in about 3.2% of ovarian cancer cases, PMV says rezatapopt could offer overall response and durable response benefits over chemotherapy.
Scrip - September 1, 2026

Simcere Zaiming Teams With Roche On Trispecific Antibody
Deal Snapshot: The Swiss pharma will partner with the Chinese firm on SIM0660, which targets CD79a, CD19 and CD3, and could work across B-cell mediated diseases spanning oncology and autoimmune diseases.
Scrip - September 1, 2026

Alumis TYK2 Inhibitor Misses In Lupus But Trial Yields Clues
The company still plans to file an NDA for envudeucitinib for psoriasis and said a prespecified analysis in the Phase IIb lupus trial suggests a path forward.
Scrip - September 1, 2026

Success For AstraZeneca And Hutchmed’s Oral Combo In First Line NSCLC
Positive topline results from the China-only SANOVO study in first-line patients help underpin Tagrisso’s dominance in EGFR-mutated lung cancer treatment
Scrip - September 1, 2026

Novartis’s Remibrutinib Scores Phase III MS Win As BTK Race Intensifies
The drug’s next test will be whether full data can translate a headline Phase III win into a meaningful position in the crowded BTK market where liver safety will be crucial.
Scrip - September 1, 2026

Scrip’s Guide To September 2026: Conferences Are Back And Novel Approvals Beckon
September will see a busier medical meeting schedule with upcoming conferences including the ERS respiratory meeting, and brisk approval activity at the US FDA. Decisions are expected for novel products for Parkinson’s and a host of rare diseases.
Scrip - September 1, 2026

Autoimmune CAR-T Double Blow As Novartis And BMS Pause Trials On Safety Concerns
Three deaths from a rare immune toxicity stopped Novartis’s trials while BMS paused its own after “transient and reversible inflammatory events.”
Scrip - September 1, 2026

Sun’s US MFN Move: Risk Mitigation And A Pricing Tightrope
Sun Pharma joins US MFN pricing pact, buying time on tariffs and betting on policy clarity as innovative medicines reshape its growth story. The firm’s global pricing architecture may have just turned a bit more sensitive, experts say.
Scrip - September 1, 2026

Merck India Chief On Building A Rare Disease Franchise From The Ground Up
As Merck prepares to foray into rare diseases in India, Pratima Reddy, managing director of Merck Specialities, is studying the landscape and assessing capabilities needed to launch Ogsiveo and Gomekli, she tells Scrip in this interview.
Scrip - September 1, 2026

Merck Specialities Head On Building A Rare Disease Franchise From The Ground Up
As Merck prepares to foray into rare diseases in India, Pratima Reddy, managing director of Merck Specialities, is studying the landscape and assessing capabilities needed to launch Ogsiveo and Gomekli, she tells Scrip in this interview.
Scrip - September 1, 2026

Advancing CNS Drug Development Through AI, New Approach Methodologies and Regulatory Innovation
Hear how emerging technologies and evolving regulatory thinking are helping sponsors navigate the complexities of neuroscience drug development.
Scrip - September 1, 2026

Longest Acting Lp(a) Inhibitor? SBP’s Kylo-11 May Reach A Year
Final results from a Phase I study of Sino Biopharmaceutical’s Kylo-11, a lipoprotein(a) siRNA candidate, showed up to 97.0% reduction of Lp(a) levels from baseline in healthy participants at 48 weeks.
Scrip - September 1, 2026

Quotables: Pharma Leaders On The Month’s Hot Topics
The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.
Scrip - September 1, 2026

GSK And Other Firms Look To Follow Moderna Into mRNA Flu Vaccine Space
Recent FDA nod for mFLUSIVA may have opened the door for other novel flu vaccine approaches. GSK is moving into Phase III, while Osivax and GC announced a T-cell program, one of an estimated 46 next-gen flu vaccine candidates advancing in the clinic.
Scrip - September 1, 2026

Trump Administration Signs Nine New MFN Deals, The First With Mid-Sized Firms
The deals with nine companies mean the MFN policy's reach now covers 89% of the branded US pharmaceutical market, according to the White House, and agreements with companies representing the remainder are expected “very soon.”
Scrip - September 1, 2026

US FDA, SEC Will Share Information, But Not Trade Secrets
Memorandum of understanding between the two agencies allows them to share non-public information in order to improve enforcement and compliance but the agreement maintains FDA’s prohibition on sharing trade secrets.
Medtech Insight - September 1, 2026

FDA Breakthrough Device Authorizations Cross 200 As Q3 Data Show Steady Designation Pace
The FDA's breakthrough devices program reached 210 market authorizations as of June 30 — crossing the 200 mark— while Q3 designations held to a pace consistent with recent years.
Medtech Insight - September 1, 2026

Two Platforms, One Playbook: Medtronic Pays For Reach In Robotics And Structural Heart
Medtronic has found a way to compete in surgical robotics and structural heart without making an all-or-nothing bet in either — two deals announced this quarter that look different on the surface but are built on the same logic: minimum commitment now, maximum optionality later.
Medtech Insight - September 1, 2026

ESC 2026: Guidelines Raise Abbott’s HeartMate 3 To Class I, Widen Device Openings Across Cardiology
The congress reset where cardiac devices sit in guidelines: Abbott's HeartMate 3 rose to Class I and CardioMEMS to IIa; J&J's Impella won its own category but not the Class I that triggers its Abiomed payout; and new rehab and CVD-CKD frameworks opened lanes for digital health and diagnostics.
Medtech Insight - September 1, 2026

Eucerin’s Probiom8 May Mark New Era In Acne Treatment
Beiersdorf reveals its highly anticipated TopiC.A active ingredient for fighting acne is launching in a regimen under the Eucerin brand.
HBW Insight - September 2, 2026

Aurobindo’s Lannett Makes Respiratory Debut With Advair Rival
Aurobindo has confirmed that its Lannett subsidiary has launched its US generic rival to Advair. But almost seven years since Lannett first struck a development deal with Respirent for the complex generic, the competitive landscape now looks very different.
Generics Bulletin - September 1, 2026

Alvotech Delivers On Promise Of Subcutaneous Vedolizumab Filing
The FDA’s acceptance of Alvotech’s AVT80 application expands its US Entyvio biosimilar program into subcutaneous presentations, as the firm positions for first-wave competition alongside intravenous candidate AVT16.
Generics Bulletin - September 1, 2026

Samsung Bioepis Makes A Start On Biosimilar Taltz Trials
Samsung Bioepis has announced the start of a Phase I trial for its SB35 biosimilar rival to Eli Lilly’s Taltz. But it is not the only developer eyeing the ixekizumab opportunity.
Generics Bulletin - September 1, 2026

PharmaPath’s Strategy for Sustainable Global Growth
CEO Eirini Vasilopoulos shares insights on scaling across global markets while maintaining a commitment to quality, transparency, and long-term partnership success.
Generics Bulletin - September 1, 2026

Civica Portfolio Grows By Three And Prices Fall Up To 98%
Civica, the US non-profit dedicated to bringing low cost and accessible generics has now added three more products to its growing portfolio, “priced up to 98% lower than average for other generic versions.”
Generics Bulletin - September 1, 2026

Who’s Hired? Reddy’s Veteran Sapra Takes Top Job At Gland
In our regular column, Generics Bulletin rounds up the most significant recent appointments across the generics and biosimilars industry.
Generics Bulletin - September 1, 2026

What’s Next? Five Things To Look Out For In September
Generics Bulletin previews the most noteworthy and anticipated events for September 2026.
Generics Bulletin - September 1, 2026

FDA Sets Sights On Vraylar And Lynparza With Latest PSGs
The FDA’s latest batch of product-specific guidances for generic development includes advice for developers of rivals to Vraylar, Lynparza, Vyvanse and Olumiant, among other products covered by the 55 new and revised PSGs.
Generics Bulletin - September 1, 2026

Strategic Intent: Beyond The Breakthrough - From Approval To Adoption
A medical device can work beautifully and still go nowhere. The conversation digs into medtech’s hardest problem — not inventing a technology, but getting physicians to switch and payers to cover it.
In Vivo - September 1, 2026

mRNA’s Next Act: Beyond Cancer And Vaccines
Moderna's melanoma data have strengthened the case for mRNA in cancer, but developers are now testing how far the technology can extend across rare diseases, respiratory medicine and cell therapy.
In Vivo - September 1, 2026