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Vividion Therapeutics to expand capabilities with new R&D centre in US

Vividion Therapeutics has announced plans to establish a new research and development centre and corporate headquarters at San Diego in California, US.

Pharmaceutical Business Review
23 Jul 2024

Apollo Therapeutics and University of Oxford sign drug discovery partnership

Apollo Therapeutics has entered into a collaboration with the University of Oxford in the UK to propel drug discovery and development.

Pharmaceutical Business Review
22 Jul 2024

Diamyd Medical secures FDA fast track status for type 1 diabetes treatment

Diamyd Medical has announced the receipt of fast track designation from the US Food and Drug Administration (FDA) for type 1 diabetes treatment, Diamyd.

Pharmaceutical Business Review
19 Jul 2024

Diamyd Medical secures FDA fast track status for type 1 diabetes treatment

Diamyd Medical has announced the receipt of fast track designation from the US Food and Drug Administration (FDA) for type 1 diabetes treatment, Diamyd.

Pharmaceutical Business Review
19 Jul 2024

Lynch Regenerative Medicine secures funds to develop skin regeneration solutions

Lynch Regenerative Medicine closed its Series A financing round for the development and commercialisation of skin rejuvenation and regeneration solutions.

Pharmaceutical Business Review
18 Jul 2024

Merck launches GMP-compliant cell culture media line in China

Merck has initiated commercial manufacturing of its first GMP-compliant manufacturing line for cell culture media (CCM) in China.

Pharmaceutical Business Review
17 Jul 2024

US FDA grants RMAT designation for Kyverna’s KYV-101

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Kyverna Therapeutics’ chimeric antigen receptor (CAR) T-cell product candidate, KYV-

Pharmaceutical Business Review
16 Jul 2024

Merck enhances ophthalmology portfolio with EyeBio acquisition

MSD (Merck & Co) has completed the acquisition of EyeBio, making it a wholly-owned subsidiary, and bolstering its ophthalmology portfolio.

Pharmaceutical Business Review
15 Jul 2024

Leqembi gains approval for Alzheimer’s treatment in Israel

BioArctic's partner Eisai has announced that Leqembi, has received approval in Israel for the treatment of Alzheimer's disease (AD), specifically for patients with mild cognitive impairment

Pharmaceutical Business Review
12 Jul 2024

Cosette Pharmaceuticals acquires Ambien rights in US

Cosette Pharmaceuticals, a US-based specialty pharmaceutical company, has expanded its portfolio by acquiring the rights to Ambien and Ambien CR in the US from Sanofi US.

Pharmaceutical Business Review
11 Jul 2024

Amneal Pharmaceuticals launches ready-to-use injectable FOCINVEZ

US-based Amneal Pharmaceuticals has announced the launch of FOCINVEZ, a ready-to-use injectable for the prevention of nausea and vomiting in chemotherapy patients.

Pharmaceutical Business Review
10 Jul 2024

Adicet Bio’s ADI-270 receives FDA Fast Track Designation for kidney cancer treatment

The US Food and Drug Administration has granted Fast Track Designation to Adicet Bio's ADI-270, a potential treatment for patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC).

Pharmaceutical Business Review
09 Jul 2024

EU approves AstraZeneca’s Tagrisso combined with chemotherapy for EGFRm NSCLC

The European Commission has approved AstraZeneca's Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with EGFRm NSCLC.

Pharmaceutical Business Review
09 Jul 2024

Alembic receives tentative approval from USFDA for Ivosidenib Tablets

Alembic Pharmaceuticals has announced tentative approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Ivosidenib Tablets, 250mg.

Pharmaceutical Business Review
09 Jul 2024

Beacon Therapeutics secures $170m to expedite gene therapy development

Beacon Therapeutics has announced a successful $170m Series B funding round, led by Forbion, to accelerate the development of its ophthalmic gene therapies.

Pharmaceutical Business Review
09 Jul 2024

FDA grants fast track status for Full-Life’s prostate cancer treatment

The US FDA has granted fast track designation for Full-Life Technologies’ 225Ac-FL-020 to treat metastatic castration-resistant prostate cancer (mCRPC).

Pharmaceutical Business Review
09 Jul 2024

Signet Therapeutics receives FDA approval for sigx1094 IND application

Signet Therapeutics has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for sigx1094.

Pharmaceutical Business Review
09 Jul 2024

EMA CHMP recommends marketing authorisation for Moderna’s RSV vaccine

The Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of marketing authorisation for Moderna's mRESVIA (mRNA-1345) vaccine.

Pharmaceutical Business Review
09 Jul 2024

FDA grants Fast Track designation to Tubulis’ TUB-040 for ovarian cancer treatment

Tubulis has received Fast Track designation from the US Food and Drug Administration (FDA) for its lead antibody-drug conjugate (ADC), TUB-040, aimed at treating patients with platinum-resistant ovarian cancer.

Pharmaceutical Business Review
09 Jul 2024

FDA approves Verona Pharma’s Ohtuvayre for COPD treatment

The US FDA has granted approval for Verona Pharma’s Ohtuvayre as maintenance therapy for chronic obstructive pulmonary disease (COPD) in adults.

Pharmaceutical Business Review
09 Jul 2024

Augustine raises €17m to advance lead candidate into trials for neuro conditions

Augustine Therapeutics has secured €17m in a Series A funding round's initial close for advancing AGT100216 into clinical trials.

Pharmaceutical Business Review
09 Jul 2024

Takeda’s LIVTENCITY receives approval in Japan for CMV infections

Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare for LIVTENCITY to treat CMV infections.

Pharmaceutical Business Review
25 Jun 2024

Juniper to distribute Caris Life Sciences’ molecular profiling services in MEA

Juniper Biologics has secured the distribution rights for Caris' advanced solid tumour molecular profiling services in the Middle East and Africa (MEA).

Pharmaceutical Business Review
24 Jun 2024
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