Posts By: pharmanewsdaily

Usona Institute gets FDA breakthrough status for psilocybin in MDD

Wisconsin-based Usona Institute has been granted breakthrough therapy designation for psilocybin from the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). According to Usona Institute, the designation secured by psilocybin for major depressive disorder acknowledges the unmet medical need in the broad population and also the potential for significant […]

ALTA-1L trial results : Takeda’s ALUNBRIG continues to show superiority over crizotinib

ALTA-1L trial results : Takeda Pharmaceutical says that ALUNBRIG (brigatinib), its tyrosine kinase inhibitor (TKI), is continuing to show superiority over crizotinib in the phase 3 ALTA-1L trial. The Japanese pharma company released updated data from the late-stage trial involving adult patients having advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who did […]

SK Biopharmaceuticals bags XCOPRI FDA approval for partial-onset seizures

XCOPRI FDA approval : SK Biopharmaceuticals said that its US subsidiary SK Life Science has been granted approval from the US Food and Drug Administration (FDA) for its anti-epileptic drug XCOPRI (cenobamate tablets) for the treatment for partial-onset seizures in adults. According to the FDA, a seizure is normally a short episode of abnormal electrical activity […]

Bristol-Myers Squibb wraps up $74bn acquisition of Celgene

Bristol-Myers Squibb has wrapped up its $74 billion acquisition of Celgene having got regulatory approval from all government authorities necessary for closing the merger agreement along with approvals from stockholders of the two companies. Celgene has now become a fully-owned subsidiary of Bristol-Myers Squibb and as per the merger terms, shareholders of the former have […]

Viking Therapeutics initiates VOYAGE study for VK2809 in NASH

Viking Therapeutics has initiated the VOYAGE study, a phase 2b clinical trial of its liver-selective thyroid hormone receptor beta agonist VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). The California-based biopharma company said that clinical trial sites have been opened for enrolling patients after it got clearance of investigational new drug (IND) application for the NASH […]

Recipharm to acquire British CDMO Consort Medical for £505m

Recipharm acquisition of Consort Medical : Swedish pharma group Recipharm has agreed to acquire Consort Medical, a British contract development and manufacturing organization (CDMO) for £505 million, as per the latest pharma acquisition news. The transaction is said to help Recipharm become a major inhalation company and places it among the top five CDMO players […]

Alkermes to acquire Boston-based neuroscience company Rodin Therapeutics

Alkermes acquisition of Rodin Therapeutics : Irish biopharma company Alkermes has agreed to acquire Boston-based neuroscience company Rodin Therapeutics in a deal worth up to $950 million as per the latest pharma acquisition news. Rodin Therapeutics is engaged in developing novel, small molecules for the treatment of synaptopathies. Alkermes acquisition of Rodin Therapeutics is said […]

Levo gets FDA fast track status for LV-101 in Prader-Willi syndrome

US biotech company Levo Therapeutics has been granted fast track designation for LV-101 (intranasal carbetocin) from the US Food and Drug Administration (FDA) for the treatment of Prader-Willi syndrome (PWS). According to the US National Library of Medicine, Prader-Willi syndrome is a complex genetic condition that impacts several parts of the body. In infancy, Prader-Willi […]

resTORbio to stop RTB101 development for symptomatic respiratory illness

resTORbio has discontinued the development of RTB101, a TORC1 inhibitor, for the prevention of clinically symptomatic respiratory illness (CSRI) after the drug failed to meet the primary endpoint of the PROTECTOR 1 Phase 3 study. The US biopharma company was conducting the PROTECTOR 1 clinical trial for assessing the safety and efficacy of RTB101 for […]

FTC clears decks for Bristol-Myers Squibb acquisition of Celgene

Bristol-Myers Squibb acquisition of Celgene : US pharma giant Bristol-Myers Squibb said that the US Federal Trade Commission (FTC) has given its clearance for its previously announced $74 billion acquisition of American biotech company Celgene. The FTC has accepted the proposed consent order regarding the pending merger of Bristol-Myers Squibb and Celgene, thereby allowing the […]

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