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BRIEF—Peter Marks resigns as CBER chief under pressure

The Center for Biologics Evaluation and Research (CBER), part of the US Food and Drug Administration, saw its top vaccine official pushed out of the post on Friday, according to people familiar with the matter, according to a Wall Street report. 29 March 2025

BRIEF—Eisai to divest warfarin rights in Japan to Sawai

28 March 2025

BRIEF—Novo Nordisk ABPI membership restored

Novo Nordisk’s two-year suspension from the Association of the British Pharmaceutical Industry (ABPI) for serious breaches of the ABPI Code of Practice has come to an end. 17 March 2025

BRIEF—Isoprotrace launched in Germany

Israel-based radiopharma company Isotopia has launched Isoprotrace in Germany, supported by distribution partner DSD Pharma. 10 March 2025

BRIEF—RFK Jr fears spreading—and there’s no vaccine

Concerns over the vaccine scepticism of the new US Department of Health and Human Services (HHS) Secretary are only increasing as Robert F Kennedy Jr (RFK Jr) settles in to his new role. 27 February 2025

BRIEF—Zevra sells Miplyffa-linked PRV for $150 million

Rare disease-focused biopharma Zevra Therapeutics has agreed to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed buyer for $150 million. 27 February 2025

BRIEF—RFK Jr nomination to head HHS clears first hurdle

US Senate lawmakers on Tuesday morning voted to advance Robert F Kennedy Jr's nomination to lead the US Department of Health and Human Services (HHS). 4 February 2025

BRIEF—AstraZeneca ditches £450 million UK investment

UK pharma major AstraZeneca has scrapped its plans to invest £450 million in expanding ($559 million) to expand its vaccine plant in Speke, Liverpool, blaming a reduction in government support. 1 February 2025

BRIEF—Evaxion raises $10.8 million in public offering

Evaxion Biotech has priced a public offering, seeking to raise $10.8 million before expenses, with closing anticipated tomorrow. 30 January 2025

BRIEF—hVIVO acquires two German clinical research units

hVIVO, a fast-growing early-stage German contract research organization (CRO) has acquired two clinical research units from Clinical Research Services (CRS), in Mannheim and Kiel, Germany, for a total of 10 million euros ($10.5 million). 29 January 2025

BRIEF—Hopes of hepatitis D breakthrough with Bluejay’s brelovitug

Privately-held US biopharma Bluejay Therapeutics has announced that its lead product candidate brelovitug—also known as BJT-778—has received US Food and Drug Administration Breakthrough Therapy designation for the treatment of chronic hepatitis D. 22 January 2025

BRIEF—MHRA backs Idorsia’s hypertension drug Jeraygo

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Jeraygo (aprocitentan) to treat hypertension (high blood pressure) in adults whose blood pressure cannot be adequately controlled by at least three other medicines (also known as resistant hypertension). 17 January 2025

BRIEF—FDA CDER director Patrizia Cavazzoni resigns

The US Food and Drugs Administration (FDA) has confirmed that Center for Drug Evaluation and Research (CDER) director, Patrizia Cavazzoni, has announced her resignation ahead of Donald Trump’s inauguration on January 20, according to media reports. 11 January 2025

BRIEF—Prefilled syringe presentation of Shingrix accepted for review by FDA

The US Food and Drug Administration (FDA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix, GSK’s recombinant zoster vaccine for the prevention of shingles (herpes zoster). 10 January 2025

BRIEF—FDA Breakthrough status for GSK’227 in osteosarcoma

UK pharma major GSK today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC) being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma (bone cancer) who have progressed on at least two prior lines of therapy. 7 January 2025

BRIEF—Centauri given $1.25m to advance antimicrobials

UK-based immunotherapy firm Centauri Therapeutics has secured a £1 million ($1.25 million) grant from PACE (Pathways to Antimicrobial Clinical Efficacy) to further develop its Alphamer technology. 25 November 2024

BRIEF—Brookfield mulls $7.4 billion bid for Grifols

19 November 2024

$800 million investment planned at GSK Pennsylvania site

GSK has announced its largest US manufacturing investment to date, dedicated to producing medicines and vaccines. 25 October 2024

BRIEF—EMA re-affirms non-renewal of masitinib and Translarna authorizations

Following a re-examination, the European Medicines Agency’s human health committee, CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorization for Masitinib AB Science’s masitinib. 18 October 2024

BRIEF—UMCG and SHINE receive $11 million grant for cancer study

University Medical Center Groningen (UMCG) and SHINE Europe have secured a 10.5 million euro ($11 million) grant to advance European production of terbium isotopes for cancer treatments. 17 October 2024

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Essential Pharma expands portfolio with Renaissance Pharma acquisition

British specialty medicines firm Essential Pharma has announced the completion of the acquisition of the entire issued share capital of fellow UK-based Renaissance Pharma. 10 April 2024

Drugs public procurements on verge of serious crisis in Russia due to failed tenders

The segment of public procurement of medicines in Russia is facing a serious crisis due to the ever-growing number of failed tenders, caused by a low interest of suppliers and drugmakers for them, The Pharma Letter’s local correspondent reports. 10 April 2024

First ever MASH drug primed for big impact in USA

Research suggests there will likely be strong uptake for the first USA-approved therapy for metabolic dysfunction-associated steatohepatitis (MASH). 9 April 2024

Six-month delay to post-Brexit rules dubbed unenforceable by industry

Nearly eight years after the UK voted to leave the European Union (EU), the government is still delaying on introducing certain new rules that impact the life sciences industry. 9 April 2024

Top-Line results from Phase III Study of Pfizer’s Abrysvo

Results from the Phase III clinical trial MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), evaluating a single dose of Abrysvo versus placebo in adults 18 to 59 years of age at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD), were released today by Pfizer. 9 April 2024

Sino Biopharma inks collaboration with Boehringer Ingelheim

Sino Biopharmaceutical revealed it has entered into a strategic partnership with Boehringer Ingelheim to bring the German family-owned company’s innovative cancer therapies to the market in mainland China. 9 April 2024

Still not happy, FDA sticks Supernus with CRL again

The US regulator has once more rebuffed efforts on the part of Supernus Pharmaceuticals to register its Parkinson’s disease candidate SPN-830. 9 April 2024

NICE backs Veklury for treatment of COVID-19 in high-risk patients

UK health technology assessor the National Institute of Health and Care Excellence (NICE) has published final draft guidance recommending use of remdesivir for treating COVID-19 in eligible adults and children. 9 April 2024

Only 43% of accelerated approval drugs showed clinical benefit in confirmatory studies

Of the 46 cancer drugs for which the US Food and Drug Administration (FDA) granted accelerated approval between 2013-2017, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials after more than five years of follow-up, according to a study presented at the American Association for Cancer Research (AACR) 2024 annual meeting. 9 April 2024

Ascletis reorders research priorities after mid-stage stumble

An FXR agonist developed by Ascletis Pharma has not performed well in mid-stage trials, leading the Hangzhou, China-based firm to dial down its investment in the drug. 8 April 2024

Esteve nabs former Lunbeck exec to be chief business development officer

Family-controlled Spanish pharma company Esteve today announced the appointment of Jacob Tolstrup as chief business development officer, part of the executive management and reporting to Staffan Schüberg, chief executive of the company. 8 April 2024

FDA approval of Dovato for adolescents with HIV

Providing continuing competition to market leader Gilead Sciences, ViiV Healthcare has achieved a new milestone in the HIV space. 8 April 2024

$40 million investment for Chinese drug developer

British life sciences investor Medicxi is betting $40 million on a Shanghai-based company, D3 Bio, working in the areas of oncology and immunology. 8 April 2024

New Phase III Jardiance data published in NEJM

The New England Journal of Medicine has published new data on Jardiance (empagliflozin) from a Phase III trial. 8 April 2024

New long-term efficacy and safety data on KarXT in schizophrenia

New interim results from the Phase III EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia were presented on Saturday at the Annual Congress of the Schizophrenia International Research Society (SIRS). 8 April 2024

The quarter with the most non-recommendations in Denmark

Denmark’s Pharmaceutical Industry Association (Lif) says that the first quarter of 2024 will be remembered as the quarter with the highest number of non-recommendations since the Medical Council introduced the new method for assessments. 8 April 2024

Acadia names former Amgen exec as new head of R&D

San Diego, USA-based drugmaker Acadia Pharmaceuticals has appointed Dr Elizabeth Thompson as executive vice president, head of R&D. 6 April 2024

Steady ahead for Novartis following year of strategic investments

An analysis of the investment activity of Novartis in recent years. 5 April 2024

Takeda wants to work with Chinese partners to bring China innovation global

In the next decade, Japan’s largest drugmaker Takeda Pharma is hoping to bring more Chinese developed drugs to the global market by working with local partners in some key therapeutic areas, said its leaders at Takeda R&D China innovation forum held in Shanghai. 5 April 2024

J&J bets big on expanding MedTech’s position with Shockwave buy

US healthcare giant Johnson & Johnson (NYSE: JNJ) has entered a definitive agreement to acquire all outstanding shares of Shockwave Medical, in a move aimed at boosting its MedTech business. 5 April 2024

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