In Brief

Refine search

BRIEF—SVF Vaccines intended merger with Novakand will not be carried out

KDventures has revealed that the planned reversed acquisition of the portfolio company SVF Vaccines by Novakand Pharma will not be completed, following Nasdaq’s rejection of an application for continued listing of the combined entity. 25 February 2026

BRIEF—Teva announces FDA filing acceptance for olanzapine NDA

Israel-based generics giant Teva Pharmaceutical Industries and France’s Medincell announced that the US Food and Drug Administration has accepted the New Drug Application for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. 21 February 2026

BRIEF—HHS limits use of fetal tissue from elective abortions

The US Department of Health and Human Services (HHS) has ended the permitted use of human fetal tissue from elective abortion in agency-funded research, applying the policy across all grants, contracts, and programs it oversees. 27 January 2026

BRIEF—FDA accepts Advicenne’s Sibnayal filing for review

French nephrology specialist Advicenne has announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Sibnayal (ADV7103), a fixed combination of potassium citrate and potassium bicarbonate for the treatment of distal renal tubular acidosis (dRTA). 19 January 2026

BRIEF—Sanofi reportedly eyeing bid for Ocular Therapeutix

French pharma major Sanofi is preparing an offer to acquire the US biopharmaceutical firm Ocular Therapeutix, according to a report by French publication La Lettre. 16 January 2026

BRIEF—Santhera wins Swissmedic approval of Agamree

Swiss pharma company Santhera Pharmaceuticals announced that the Swiss Agency for Therapeutic Products (Swissmedic), has approved Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older. 15 January 2026

BRIEF—MHRA urges public to avoid illegal online weight-loss medicines

As many people consider lifestyle changes at the start of the year, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is urging the public to make sure any weight-loss medicines they use are safe, effective and legitimate. 29 December 2025

BRIEF—FDA nod for first Rx oral med for iron deficiency in pediatric patients

The US Food and Drug Administration (FDA) has approved Accrufer (ferric maltol) capsules to treat pediatric patients ages 10 and older with iron deficiency. 24 December 2025

BRIEF—FDA approves Jansen’s Akeega for mCSPC

On December 12, 2025, the US Food and Drug Administration approved Johnson & Johnson subsidiary Janssen Biotech’s Akeega (niraparib and abiraterone acetate with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test. 15 December 2025

BRIEF—Lilly is first pharma group to be valued at $1 trillion

US pharma giant Eli Lilly’s weight-loss drugs have made it the first pharma company to hit a $1 trillion market valuation, a sharp turnaround from this summer when its stock was hit by disappointing results for a new obesity pill orforglipron, according to the Financial Times. 22 November 2025

BRIEF—Shionogi launches new form of Xofluza

Japanese drugmaker Shionogi has announce the launch of a new formulation of the anti-influenza virus drug Xofluza (baloxavir marboxil) Granules 2%. 12 November 2025

BRIEF—Non-fee FDA submissions update

The US Food and Drug Administration (FDA) on Friday posted an update to let industry know that the agency can still accept submissions for fiscal year 2026 that do not require a fee payment and for which FDA review work is covered by available carryover user fee funding. 1 November 2025

BRIEF—Sanofi successfully prices $3 billion bond issue

French pharma major Sanofi this morning revealed that it has successfully priced its offering of $3 billion of notes across 5 tranches: 28 October 2025

BRIEF—smartbax raises 4.7 million euros for new antibiotic programs

German biotech smartbax has raised 4.7 million euros ($5 million) in a pre-series A round led by Anobis Asset and Bayern Kapital. UnternehmerTUM Funding for Innovators, HTGF, and Boehringer Ingelheim Venture Fund also joined. A second closing remains open to new investors. 22 October 2025

BRIEF—Santhera inks deal for Agamree distribution in Russia

Swiss specialty drugmaker Santhera Pharmaceuticals has announced the signing of an exclusive agreement with Biomedica for the distribution of Agamree (vamorolone) in Russia, for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older. 9 October 2025

BRIEF—Soligenix raises $7.5 million to advance HyBryte

US biopharma Soligenix has priced a $7.5 million public offering. Proceeds will fund research, commercialization, and corporate purposes, with A.G.P./Alliance Global Partners acting as sole placement agent. 26 September 2025

BRIEF—FDA drops need for AdCom on Biohaven’s troriluzole

Shares in Biohaven moved up about 7% on Friday after the company provided an update with respect to its New Drug Application (NDA) for troriluzole for the treatment of adult patients with spinocerebellar ataxia (SCA), in a filing with the Securities and Exchange Commission (SEC). 26 August 2025

BRIEF—NHI drug price listing and launch of Mochida’s Lialda in Japan

Japan’s Mochida Pharmaceutical has announced that Lialda (mesalazine 600mg)the will be launched on September 8, 2025, as the NHI (National Health Insurance) Drug Price was listed on August 14, 2025. 18 August 2025

BRIEF—Boehringer’s Hernexeos gains NCCN recommendation

German family-owned pharma major Boehringer Ingelheim announced that Hernexeos (zongertinib tablets) has been recommended as a preferred subsequent therapy option for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with ERBB2 (HER2) mutations who received prior systemic therapy in the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for non-small cell lung cancer (Version 8), updated on August 15, 2025 16 August 2025

BRIEF—Rising tariffs on pharma to reach 250%, Trump warns

The initial small tariff on pharmaceutical imports will be increased to 150% within 18 months and eventually to 250%, according to President Trump’s comments in a CNBC interview. 7 August 2025

12 3 4 5 6 7 8 9 10 Next page

By George Medicines, another GMRx2 deal

Days after announcing an exclusive licensing and supply agreement with South Korean pharma company Ahngook Pharmaceutical, George Medicines has announced another deal relating to GMRx2. 16 March 2026

Deal gives Sentynl shot at second HGPS treatment

Sentynl Therapeutics, a USA-based biopharma and wholly-owned subsidiary of India’s Zydus Lifesciences, has announced a deal with Korean rare genetic diseases specialist PRG S&T to license its investigational molecule progerinin (SLC-D011) for Hutchinson-Gilford progeria syndrome (HGPS). 16 March 2026

Sovereign wealth funds: the new life science kingmakers?

Sovereign wealth funds once appeared only intermittently in life-science financing. Their money surfaced through venture funds or private equity partnerships, usually at one remove from the operating companies themselves. Over the past decade that distance has narrowed, particularly as Gulf investors have become more comfortable deploying capital directly. 16 March 2026

New Kerendia top-line data for adults with non-diabetic CKD

The Phase III study FIND-CKD investigating the efficacy and safety of Kerendia (finerenone) versus placebo when added to standard of care in adult patients with non-diabetic chronic kidney disease (CKD) - has met its primary endpoint. 16 March 2026

Ternary raises £3.6m to develop AI-designed molecular glue drugs

Young British biotech Ternary Therapeutics has raised £3.6 million ($4.6 million) in seed funding to advance an artificial intelligence platform designed to create “molecular glue” drugs, compounds that force two proteins inside cells to bind together and alter disease-driving biology. 16 March 2026

Taiwan unveils $755 million plan to strengthen domestic drug supply

Taiwan is preparing a four-year pharmaceutical resilience program backed by NT$24 billion ($755 million) to reduce reliance on imported medicines and strengthen domestic manufacturing. 16 March 2026

Samsung Bioepis and Epis NexLab to develop long-acting semaglutide

South Korea-based Samsung Bioepis and Epis NexLab Co, a sister company to Samsung Bioepis under Samsung Epis Holdings, have announced a research collaboration and license agreement with G2GBIO, a company specializing in the development of sustained-release formulations, to develop novel assets based on G2GBIO’s proprietary microsphere technology. 16 March 2026

Investment in cancer care across Europe has paid off, report says

Europe is achieving better cancer outcomes without cancer overwhelming health budgets, according to the Comparator Report on Cancer in Europe 2025 by the Swedish Institute for Health Economics (IHE). 16 March 2026

CMS announces third cycle of Medicare drug price negotiation

Under the Medicare Drug Price Negotiation Program (Negotiation Program), the US Centers for Medicare & Medicaid Services (CMS) directly negotiates the prices of certain high expenditure, single source drugs without generic or biosimilar competition. 16 March 2026

Regulatory round-up: 16 March 2026

Global drug regulators have continued to move a steady stream of approvals and recommendations through early March, with activity spanning oncology, vaccines, and regulatory policy discussions. The US Food and Drug Administration (FDA) issued a notable oncology approval, while the European Medicines Agency (EMA) highlighted multiple new medicines recommended by its scientific committee. 16 March 2026

NCCN recommends Boehringer’s Hernexeos as an initial treatment option

Boehringer Ingelheim announced that Hernexeos (zongertinib tablets) has been recommended as an initial treatment option for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) in the latest National Cancer Comprehensive Network) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for non-small cell lung cancer (Version 5.2026), updated on March 13, 2026. 15 March 2026

The week in pharma: action, reaction and insight – week to March 13, 2026

Important research news last week included Vertex announcing positive Phase III results for its povetacicept in immunoglobulin A nephropathy. And, BridgeBio reported positive Phase III results for BBP-418 in muscular dystrophy. Also of note, German biotech BioNTech revealed that its co-founders were planning to leave the company, along with 2025 financial results. 15 March 2026

Otsuka unveils new repinatrabit data in PKU

armaceutical Development & Commercialization and its parent Japan-based Otsuka Pharmaceutical have announced new open-label extension study data for repinatrabit (JNT-517), demonstrating early and clinically-meaningful reductions in blood phenylalanine (Phe) levels (-67% mean change from baseline) in adolescents with phenylketonuria (PKU). 13, 2026 13 March 2026

Bayer in UK code breach over Eylea

The Prescription Medicines Code of Practice Authority (PMCPA)—which operates the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI)—has rapped Bayer over its conduct. 13 March 2026

EMA outlines new AI and data roadmap for medicines regulation

The European Medicines Agency and national regulators across the European Union have published a workplan outlining how artificial intelligence and large health datasets will be used to support medicines regulation over the coming years. 13 March 2026

Eli raises new funds to push radiopharma pipeline

Chinese radiopharmaceutical startup Eli Radiopharma has secured around 100 million yuan ($14.5 million) in fresh financing as it expands its pipeline and deepens industry partnerships. The Hangzhou-based company said the funds will support target discovery, platform development and clinical translation across oncology and neurological disease programs. 13 March 2026

PRISM BioLab and Receptor.AI collaborate on molecule discovery

Japan’s PRISM BioLab and USA-based Receptor.AI Inc have entered into a drug discovery collaboration agreement to develop an integrated, AI-navigated, physics-guided platform for the discovery of orally available small molecules targeting intracellular protein–protein interactions (PPIs), membrane proteins, and complex receptor systems. 13 March 2026

Lilly flags impurity risk in compounded tirzepatide

US drugmaker Eli Lilly has warned that compounded versions of tirzepatide mixed with vitamin B12 may contain a previously unidentified impurity, raising fresh safety concerns around copycat formulations of its blockbuster GLP-1 therapy. 13 March 2026

Colin Hayward named Ratio CMO

Ratio Therapeutics, a US pharma company developing radiopharmaceuticals for cancer treatment and monitoring, has announced the appointment of Colin Hayward as chief medical officer (CMO). 13 March 2026

Lilly to spend $3 billion on strengthening supply chain presence in China

Eli Lilly has announced plans to invest a total of $3 billion over the next 10 years to comprehensively expand its supply chain capacity in China. 12 March 2026

12 3 4 5 6 7 8 9 10 Next page

Copyright © The Pharma Letter 2026

| Headless Content Management with Blaze