Pharmaceuticals & Biopharmaceuticals

Lupin Launches Generic Raltegravir in US, Gains 180-Day Exclusivity

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Lupin Launches Generic Raltegravir in US, Gains 180-Day Exclusivity

MUMBAI – – November 03, 2026 -- Lupin Limited has launched Raltegravir Tablets USP, 600 mg in the United States and is eligible for 180-day generic drug exclusivity, after the U.S. FDA approved its Abbreviated New Drug Application.

The product is bioequivalent to the reference listed drug Isentress HD Tablets, 600 mg, marketed by Merck Sharp & Dohme, LLC. Lupin is the exclusive first-to-file applicant for the product.

Reference product generated an estimated USD 26 million in annual US sales

Isentress HD 600 mg had estimated annual U.S. sales of USD 26 million, according to IQVIA MAT September 2026 data. That figure is the market the 180-day exclusivity window covers for Lupin.

Thryv Raises $30M Series B Led by InClin for Heart Failure Trial

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Thryv Raises $30M Series B Led by InClin for Heart Failure Trial

SAN FRANCISCO – November 03, 2026 -- Thryv Therapeutics Inc. has raised a $30 million Series B financing led by InClin, Inc., a global contract research organization, to move its SGK1 inhibitor THRV-1268 into a Phase 2a heart failure study that opens for enrollment in early 2027.

The round follows completion of enrollment in the first efficacy cohort of the Wave II Phase 2/3 study of THRV-1268 in Long QT Syndrome. It also follows a favorable review of available Wave II data by the study's Independent Data Monitoring Committee (IDMC).

InClin brings clinical operations alongside capital

InClin, which operates in San Mateo, California and Sydney, Australia, joins as a strategic investor. In recent months Thryv has worked with the CRO to establish clinical operations in Australia, enabling initial patient enrollment in ASPIRE-HF early next year.

Spektus, GEBRO Split Global Rights to ActraFlex Pain Drug

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Spektus, GEBRO Split Global Rights to ActraFlex Pain Drug

Laval – November 03, 2026 -- Spektus Pharma and GEBRO Holding have agreed a global commercialization partnership for ActraFlex, a twice-daily extended-release tramadol/paracetamol formulation for pain management.

GEBRO takes Europe and Spektus takes the Americas under a split-territory deal

GEBRO, headquartered in Fieberbrunn, Austria, will lead commercialization and supply across Europe and selected international markets. The rollout is anchored by Spain, where GEBRO's Diliban brand has an established commercial presence.

Spektus, a Canadian specialty pharmaceutical company, will lead commercialization and supply across the Americas and selected markets in Africa and Asia. It will work through its network of regional pharmaceutical partners.

Each company will lead regulatory approvals in its own territories.

Neurocrine Q3 Revenue Jumps 41% to $1.1B, Lifts INGREZZA Guidance

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Neurocrine Q3 Revenue Jumps 41% to $1.1B, Lifts INGREZZA Guidance

SAN DIEGO – November 02, 2026 -- Neurocrine Biosciences (Nasdaq: NBIX) grew third-quarter 2026 revenue 41% year over year to $1.1 billion, up from $795 million, and raised its full-year INGREZZA net sales guidance to $2.9 billion to $2.925 billion.

The prior INGREZZA range was $2.825 billion to $2.875 billion. Net product sales topped $1 billion for the first time, according to the company.

INGREZZA sales rise 17% to $801 million on double-digit volume growth

INGREZZA growth reflected record TRx and NRx and high persistency rates. CRENESSITY contributed $211 million, with approximately 80% reimbursement for dispensed prescriptions. VYKAT XR added $107 million.

Neurocrine acquired VYKAT XR through its purchase of Soleno Therapeutics, which closed in May 2026. The company recorded about $2.2 billion of VYKAT XR intellectual property on its balance sheet, to be amortized over an expected 16 years.

Novartis Ends BioArctic BrainTransporter Deal, Keeps $30M Upfront

STOCKHOLM – November 02, 2026 -- BioArctic AB will keep the full USD 30 million upfront payment from Novartis Pharma AG after Novartis terminated their Option, Collaboration and License Agreement, the Nasdaq Stockholm-listed company (BIOA B) announced.

Novartis drops the program, not the technology

The agreement was signed in August 2025. It covered a potential new treatment combining BioArctic's proprietary BrainTransporter technology with an undisclosed Novartis proprietary antibody. Novartis notified BioArctic that it decided to discontinue the program. According to BioArctic, the decision is unrelated to the BrainTransporter technology.

BioArctic books the remaining upfront payment as 2026 revenue

Because of the termination, BioArctic will recognize the remaining unrecognized portion of the USD 30 million upfront payment as revenue in 2026. The company did not disclose the size of that portion.

PharmaForceIQ Launches Share of Answer to Fix Pharma AI Visibility

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PharmaForceIQ Launches Share of Answer to Fix Pharma AI Visibility

MIAMI – November 02, 2026 -- Brand and condition websites account for just 17% of AI-answer citations on average, according to PharmaForceIQ audits behind the launch of Share of Answer, a new module in its Optichannel 360 platform for biopharma companies.

Audits find retired webpages and superseded FDA labeling in AI answers

The audits identified citations to hundreds of retired webpages. In one analysis, AI-generated responses quoted superseded FDA-approved labeling in nearly 250 answers.

Abbreviations also caused errors. In a rare disease analysis, AI engines identified the condition correctly when prompted with its full name, but more than half of the answers failed to identify it when an abbreviation was used.

Sobi to present six gout abstracts at ACR Convergence 2026

Stockholm – November 03, 2026 -- Sobi (STO: SOBI) will present six abstracts on two late-stage gout assets, pozdeutinurad (AR882) and nanoencapsulated sirolimus plus pegadricase (NASP), at ACR Convergence 2026, the American College of Rheumatology annual meeting, in Orlando, Florida, on 6–11 November 2026.

Phase 3 REDUCE-2 results for pozdeutinurad headline the program

The presentations include results from the Phase 3 REDUCE-2 study of pozdeutinurad, an investigational once-daily oral, highly selective URAT1 inhibitor for uncontrolled gout. REDUCE-2 is one of two 12-month, randomised, double-blind, placebo-controlled Phase 3 studies, alongside REDUCE-1, that are evaluating the drug in more than 800 patients. Both trials assess its ability to lower serum urate (SU) in patients with uncontrolled gout.

Earlier Phase 2 studies showed a sustained SU reduction, dissolution of tophi and a generally well-tolerated safety profile, according to Sobi.

Moberg Pharma Wins U.S. Patent on MOB-015 Dosing, Expiry 2041

STOCKHOLM – November 03, 2026 -- The U.S. Patent and Trademark Office has granted Moberg Pharma a patent on an improved dosing regimen for MOB-015, its topical onychomycosis drug, with a projected expiry in December 2041. The U.S. is the first market to grant a patent on the new dosing.

Patent draws on European approval studies and North American Phase 3 data

The patent covers new dosing approaches for MOB-015. It rests on clinical results from the studies behind the European approval and from the company's most recently completed Phase 3 study in North America. Dosing patent applications in other markets remain under examination.

IDEAYA files darovasertib NDA and ends Phase 3 trial; cash at $1.15B

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IDEAYA files darovasertib NDA and ends Phase 3 trial; cash at $1.15B

SOUTH SAN FRANCISCO – November 03, 2026 -- IDEAYA Biosciences (Nasdaq: IDYA) completed its first new drug application for darovasertib plus crizotinib in metastatic uveal melanoma during the third quarter, and ended the quarter with $1.15 billion in cash, cash equivalents and marketable securities as of September 30, 2026. Cash runway guidance into 2030 is unchanged.

PAQ to Present First Clinical Data for KRAS G12D Degrader PT0253

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PAQ to Present First Clinical Data for KRAS G12D Degrader PT0253

Burlington – November 03, 2026 -- PAQ Therapeutics will present the first clinical data for PT0253, its selective KRAS G12D degrader, in a late-breaking oral session at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026) in Barcelona, Spain, on November 20.

Phase 1 data in advanced solid tumors will cover safety and antitumor activity

The presentation reports findings from the company's ongoing Phase 1 trial in patients with advanced solid tumors. The abstract title (6LBA) describes a differentiated safety profile and antitumor activity for PT0253, including in patients who received prior (K)RAS-targeted therapy.

The slot is scheduled for 12:36-12:44 p.m. CET in Plenary Session 6, "Proffered Papers: Advances in Targeting RAS." ENA 2026 runs November 18-20.