Featured Stories

Jardiance Improves Double-Digit Growth Potential With US Approval In CKD
Boehringer expects Jardiance’s new chronic kidney disease indication to keep its sales growing by double-digit percentages over the coming years, aided by the drug’s ability to reduce hospitalizations.

Seagen, Astellas Data Support Broader Indication For Padcev/Keytruda Combo
With accelerated approval in advanced urothelial cancer, the sponsors now have data that could support full approval plus a move into first-line therapy.

Promising Early Results For AZ And Daiichi’s Dato-DXd In Breast Cancer – But How Soon Can They File?
Once again choosing their words carefully, the partners talk only of ‘plans’ to file as regulators will first have to clarify when overall survival data will be required for the new antibody-drug conjugate in breast cancer.
Asia Spotlight
Sun Backs India-First Stroke Drug From Pharmazz
Sun debuts Pharmazz Inc’s new stroke drug sovateltide in India at under $20/ vial. The selective endothelin-B receptor agonist, which can be administered up to 24 hours post cerebral ischemic stroke, is also being studied in Alzheimer’s disease.
Latest News
Scrip Originals

Deal Watch: Merck KGAA Teams With AI Biotechs On Drug Discovery Efforts
Plus deals involving Debiopharm/SunRock, RefleXion/3B Pharmaceuticals, Pharmanovia/Sanofi and more.

Finance Watch: ReCode’s Series B Mega-Round Grows Again With $50m Boost
Private Company Edition: ReCode’s series B venture capital round grew for a third time, now totaling $260m for precision genetic medicines. Also, DalCor closed an $80m series D, manufacturer Nephron amassed $350m, Hyku launched with a $56m seed financing and Magnet emerged with $50m.

GSK Reorganizes Around Key R&D Areas As Lepore Exits
The UK-based company has replaced its single head of research with four therapy area-focused leaders as it looks to further boost R&D productivity.

Pipeline Watch: Five Approvals And 28 Phase III Updates
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Interviews

Newly Unveiled Ampersand's CEO On ‘Programmable’ Medicines And Flagship’s Winning Formula
Ampersand Biomedicines has emerged from stealth mode with a new CEO, and aims to shake up oncology and immunology with a new tissue-specific approach to targeting medicines.

BioAge Looks To Tackle Diseases Of Aging, Starting With Muscle Loss
Emerging Company Profile: BioAge has Phase Ib proof-of-concept data in age-related muscle loss and is gearing up for its first Phase II study, but will need fresh cash or a partner for a potential weight loss-related muscle loss study.

Mironid Gets Roche Backing To Tackle Hereditary Kidney Disease
These are interesting times for Mironid, a Glasgow-based biotech developing small molecule therapeutics for the treatment of autosomal dominant polycystic kidney disease, a life-threatening hereditary condition.

India M&A Hourglass: Control Deals, ‘FOMO’, Monetization Calls At Family-Owned Firms
The founder and MD of investment bank Candle Partners reflects on key pharma M&A trends over the years and the shape of things to come including private equity action and how family-owned firms are weighing monetization and diversification options.
Graphics

Infographic: A Snapshot Of Non-Alcoholic Steatohepatitis R&D
After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.

Top 10 Best-Selling Drugs Of Q2 2023: COVID-19 Out, HPV In
The Merck & Co vaccine for human papillomavirus Gardasil, along with Johnson & Johnson’s Darzalex for multiple myeloma, entered the ranks of the top 10 best-selling drugs globally in the second quarter. There was no product for COVID-19 in the line-up for the first time since 2020.

A Closer Look: Commercial Impact For Drugs Up For Medicare Price Negotiation
An infographic looking at commercial factors for the 10 drugs chosen for Medicare price negotiation in 2026 under the Inflation Reduction Act (IRA). The graphics below review the valuations of these drugs, both past and forecast, as well as their relative contributions to the top-lines of the companies that own them.

Patent Cliff Likely Accelerated By Two Years For Most Drugs On Medicare Price Negotiation List
The Class of ’26 of Medicare Price Negotiation University is now on stage. Our infographic profiles who they are and where they come from, breaking down the $50.5B in gross annual Part D spending, about 20% of the total.
Recent Stories
Two LEAPs Behind: Merck/Eisai Post Pair Of Failures Of Keytruda/Lenvima Combo
The announcement that LEAP-006 and LEAP-008, both in non-small cell lung cancer, did not meet their primary endpoints adds to a string of failures for the combination.
Deal Watch: Merck KGAA Teams With AI Biotechs On Drug Discovery Efforts
Plus deals involving Debiopharm/SunRock, RefleXion/3B Pharmaceuticals, Pharmanovia/Sanofi and more.
Executives On The Move: C-Suite Changes At ImmunoGen, Kronos Bio, Verve Therapeutics And More
Recent executive moves in the industry include new CEOs at Rentschler Biopharma, MedinCell and OncoZenge, plus C-suite changes at Hinova Pharmaceuticals and ImmunoGen.
BenevolentAI Still Bullish As CEO Shields Steps Down
BenevolentAI has added Merck KGaA to its list of partners but the UK firm is looking for a new CEO after Joanna Shields decided to leave as a major restructuring continues.
Glenmark Divests API Company, Setting Out On Distinct Journeys
Glenmark Pharmaceuticals has divested its API arm to the Nirma group for over $681m, a move that will deleverage the drug maker’s balance sheet as it seeks to evolve into an “innovative/brand led organization.”
Infographic: A Snapshot Of Non-Alcoholic Steatohepatitis R&D
After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.
A Look Into The Future Of NASH
The liver disease is one of the hottest areas of drug development. Here are some upcoming catalysts to look out for.
Travere Hopes For FDA Full Approval Despite Filspari Trial Endpoint Miss
The company said the “totality of data” from the confirmatory PROTECT trial in IgA nephropathy showed the drug slowed decline in kidney function.
Genentech Joins Hunt For ‘Molecular Glue’ Drugs With Orionis
Genentech is broadening its stake in the protein degradation field, following BMS and Merck & Co into molecular glue drugs.
All Systems Go At Almirall To Enter Tough Atopic Dermatitis Market With Ebglyss
Following a positive opinion from the CHMP, the Spanish company is hoping to launch its challenger to Dupixent in the EU before the end of the year.
A Year And A Half After Giving Up On TAK-721, Takeda Seeks Approval In EoE
The US FDA rejected TAK-721 for eosinophilic esophagitis (EoE) in 2021, requiring another study, and Takeda ended development in 2022, but in a newly accepted NDA it is seeking a short-term treatment indication.
Relmada Hopes Open-Label Efficacy, Safety Bolster Profile Of Depression Candidate
With a pair of Phase III setbacks due to high placebo response, Relmada reports positive efficacy and safety data from an open-label trial while awaiting data from two ongoing pivotal studies for REL-1017, an NMDA antagonist.
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