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BRIEF—Third Harmonic announces pricing of upsized IPO

Third Harmonic Bio, a clinical-stage biopharmaceutical company developing a potent, highly selective, oral KIT inhibitor for the treatment of severe inflammatory diseases, has announced the pricing of its upsized initial public offering of 10,900,000 shares of its common stock at a public offering price of $17 per share. 15 September 2022

BRIEF—Lumicef submitted for new indication in Japan

Japanese drugmaker Kyowa Kirin has submitted to broaden the Japanese label for Lumicef (brodalumab), to include the treatment of the uncommon autoimmune disorder palmoplantar pustulosis (PPP). 15 September 2022

BRIEF—J&J announces $5 billion share repurchase program

Johnson & Johnson has announced that the board of directors has authorized the repurchase of up to $5 billion of the company's common stock. 14 September 2022

BRIEF—EU COVID-19 vaccine procurement

Most COVID-19 vaccine contracts signed by the European Commission lacked specific provisions to address supply disruptions, and procurement processes could have been more scrutinized, the European Court of Auditors (ECA) found in a new report released Monday. 13 September 2022

BRIEF—Alnylam seeks to raise $900 million in offering

RNAi therapeutics company Alnylam has commenced a private offering of $900 million aggregate principal amount of convertible senior notes. 12 September 2022

BRIEF—FDA and EMA accept Pfizer's filings for alopecia candidate ritlecitinib

The US Food and Drug Administration (FDA) has accepted Pfizer’s New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. 10 September 2022

BRIEF—NIH starts enrollment for US clinical trial evaluating TPOXX for monkeypox

On Friday, the US National Institutes of Health (NIH), the nation’s medical research agency, announced the start of enrollment for a Phase III USA- based clinical trial evaluating tecovirimat (trade name TPOXX) for the treatment of monkeypox. 10 September 2022

BRIEF—CMO among Nouscom appointments

Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vectored immunotherapies, has announced the promotion of Sven Gogov to chief medical officer (CMO) and the appointment of Maria Arce-Tomas as vice president, head of regulatory affairs. 9 September 2022

BRIEF—Merck increases manufacturing capacity for vaccines

German science and technology company Merck KGaA is strengthening its manufacturing capabilities for single-use assemblies, a key technology for the production of COVID-19 vaccines and other lifesaving therapies, by investing more than 130 million euros ($129 million) in Molsheim, France. 8 September 2022

BRIEF—Lynparza OKed in Great Britain for early-stage breast cancer

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a new marketing authorization for Lynparza (olaparib) in Great Britain 6 September 2022

IN BRIEF—Takeda hands over keys to Norwegian facility

Japanese pharma major Takeda has entered into an agreement for the acquisition of its manufacturing site in Asker, Norway, by NextPharma, a contract development and manufacturing organization (CDMO). 6 September 2022

BRIEF—Merck debuts 60 million-euro Launch and Technology Center in Darmstad

Germany’s Merck KGaA today announced it is investing 160 million euros ($159 million) in a new facility in Darmstadt — the Launch and Technology Center — to further speed up the availability of future pharma medicines for patients in need. 6 September 2022

BRIEF—India to debut first indigenous vaccine against cervical cancer

India’s Minister of State of the Ministry of Science and Technology & Earth Sciences announced India’s first indigenously developed quadrivalent human papillomavirus vaccine (qHPV), Cervavac, for the prevention of cervical cancer. 5 September 2022

BRIEF—FDA approval for Orkambi in infants under two years

The US Food and Drug Administration (FDA) on Friday approved expanded use of Orkambi (lumacaftor/ivacaftor) to include children with cystic fibrosis (CF) ages 12 to 3 September 2022

BRIEF—EMA/CHMP backs approval of bivalent COVID-19 vaccine boosters

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended authorizing two vaccines adapted to provide broader protection against COVID-19, just a day after the US Food and Drug Administration did likewise. 1 September 2022

BRIEF—FDA nod for two bivalent COVID-19 vaccine booster

Much as has been expected US Food and Drug Administration (FDA) has quickly granted amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. 31 August 2022

BRIEF—Recordati's Isturisa data published in European Journal of Endocrinology

The long-term outcomes from the open-label extension period of the Phase III LINC 3 study of Recordati’s Isturisa (osilodrostat) have been published in The European Journal of Endocrinology. 31 August 2022

BRIEF—Marinus sells priority review voucher for $110 million

Marinus Pharmaceuticals, a pharmaceutical company developing therapeutics to treat seizure disorders, has announced that it has closed on the sale of its Rare Pediatric Disease Priority Review Voucher for $110 million. 30 August 2022

BRIEF—FTC authorizes resolutions for investigations of M&A

The US Federal Trade Commission (FTC) announced on Friday that it has approved three omnibus resolutions authorizing compulsory process in investigations, one of which related to mergers, acquisitions, and transactions. 27 August 2022

BRIEF—Pfizer and BioNTech complete EMA filing for Omicron BA.4/BA.5 adapted bivalent vaccine

BioNTech and Pfizer just announced that they completed their submission to the European Medicines Agency (EMA) for a variation of the conditional marketing authorization to include a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years and older. 26 August 2022

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Alloy and Takeda team up on CAR-T cell platform

Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024

Eisai announces launch of Rozebalamin and Tasfygo

Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024

Merck: a relentless pursuit of the best outcomes for the entire MS community

Germany's Merck has spent more than 25 years researching and developing solutions for advancing multiple sclerosis (MS) care. 21 November 2024

Cidara to raise up to $105 million in private placement

San Diego-based Cidara Therapeutics, a biotech using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, has entered into a securities purchase agreement with certain investors to raise up to around $105 million. 21 November 2024

Novartis upgrades mid-term guidance; buys Kate Thera

Swiss pharma giant Novartis today announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. 21 November 2024

FDA approves Jazz’s Ziihera for HER2+ biliary tract cancer

The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024

Lilly and Laekna team up on novel obesity drugs

Eli Lilly is not resting on its laurels when it comes to the fast-growing field of obesity treatments, an area in which it is already a leader. 21 November 2024

Aizen hopes AI will help make mirror peptides a reality

Aizen Therapeutics, an AI-driven biotech headquartered in San Diego, has officially launched from stealth mode, introducing its drug discovery platform, DaX. 21 November 2024

$30 million validation for Valora

San Diego-based Valora Therapeutics, a biotech that boasts of having a novel approach to immunotherapy, has announced the successful closing of a $30 million seed funding round. 21 November 2024

Astellas’ loss is Apellis’ gain as FDA setback shakes up prospects

Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024

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UK reappoints BIA chairman as life sciences investment envoy

The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 21 November 2024

Sage scraps dalzanemdor after disappointing trial results

Sage Therapeutics will down tools on its dalzanemdor program, after the Phase II DIMENSION trial missed both primary and secondary endpoints. 21 November 2024

Kura and Kyowa Kirin sign ziftomenib deal

San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024

HCW Biologics takes aim at CD8+ in deal with WY Biotech

HCW Biologics has announced a worldwide licensing agreement with WY Biotech to develop and commercialize one of its preclinical immunotherapy candidates. 21 November 2024

Leading Tac secures $14 million for IRAK4 degraders

Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024

Positive top-line data for NewAmsterdam’s obicetrapib and ezetimibe combo

Dutch clinical-stage biotech NewAmsterdam Pharma, which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial. 21 November 2024

Amgen names new president of research

US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024

Vyriad collaborates with Novartis on in vivo CAR-T cell therapies

US clinical-stage biotech Vyriad has entered into a strategic collaboration with Swiss pharma giant Novartis to discover and develop in vivo chimeric antigen receptor (CAR) T-cell therapies. 21 November 2024

EC approval for Pfizer’s Hympavzi

The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024

Flagship reveals new agreements under Pfizer link-up

Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024

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