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Pharmaceutical
The European Medicines Agency (EMA) has launched a secure online platform for submitting and managing parallel distribution notifications through the recently implemented IRIS Regulatory & Scientific Information Management Platform. 11 February 2019
Pharmaceutical
German drugs and Chemical group Merck KGaA today announced a $70 million investment to expand its state of the art research and development (R&D) facility in Billerica, Massachusetts. 6 February 2019
Pharmaceutical
Japanese drugmaker Takeda has withdrawn the US filing that asked for a further indication with its multiple myeloma drug Ninlaro (ixazomib). 5 February 2019
Pharmaceutical
Dutch firm argenx has partnered with US-based Halozyme Therapeutics to leverage the latter’s ENHANZE drug delivery tech. 4 February 2019
Pharmaceutical
Ireland-incorporated Alkermes has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for ALKS 5461 (buprenorphine/samidorphan) for the adjunctive treatment of major depressive disorder (MDD). 4 February 2019
Pharmaceutical
The European Commission is consulting on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another. 1 February 2019
Pharmaceutical
Mauritius-based InvAscent has raised $250 million for its India Life Sciences Fund, a private equity vehicle focused on the pharmaceutical and healthcare industries. 1 February 2019
Pharmaceutical
Japan’s Daiichi Sankyo has agreed terms with Taiyo Holdings to sell its Takatsuki-based plant, which is responsible for manufacturing pharmaceuticals. 1 February 2019
Pharmaceutical
Japanese pharma major Eisai has filed a supplementary new drug application (sNDA) in Japan for its in-house discovered antiepileptic drug (AED) Fycompa (perampanel) seeking approval for use as monotherapy for partial-onset seizures, treatment for partial-onset seizures in pediatric patients aged four years and older, as well as a new fine granule formulation. 31 January 2019
Pharmaceutical
Swedish Orphan Biovitrum (Sobi) announces that Ravicti (glycerol phenylbutyrate), a therapy option for the treatment of patients with urea cycle disorders (UCDs), had received approval from the European Commission on December 18, 2018 for the pediatric indication (birth to two months of age) following a positive opinion from the European Medicines Agency advisory committee, CHMP. 30 January 2019
Pharmaceutical
US biotech Genetic Immunity is expanding a collaboration with JSC Pharmadis, granting licenses for twenty cancer indications for products created using its transdermally delivered pDNA-based vaccine technology. 29 January 2019
Pharmaceutical
Indian Contract Research Organizations (CRO) Lambda Therapeutic Research has reached an agreement to acquire Novum Pharmaceutical Research Services, a leading CRO in the USA, in a private transaction. 29 January 2019
Pharmaceutical
Japan’s Sumitomo Dainippon Pharma today announced today that the Chinese National Medical Products Administration (NMPA) has granted an import drug license for Latuda (lurasidone hydrochloride), an atypical antipsychotic, for the treatment of patients with schizophrenia. 29 January 2019
Pharmaceutical
Vertex Pharmaceuticals has won approval in Canada for Kalydeco (ivacaftor) to include use in 1-2 year olds with cystic fibrosis (CF), with certain genetic modifications. 29 January 2019
Pharmaceutical
Following the publication of positive Phase III data for Barhemsys (amisulpride) in the journal Anesthesiology, Cambridge, UK-based Acacia Pharma has welcomed an accompanying editorial assessing the trial’s significance. 28 January 2019
Pharmaceutical
As it goes about raising money to pay for the $62 billion takeover of rare diseases specialist Shire, Takeda has announced a plan to sell of property assets. 28 January 2019
Pharmaceutical
Acerus Pharmaceuticals has received a Notice of Deficiency-Withdrawal Letter for its Gynoflor, an ultra-low dose vaginal estrogen therapy with the addition of lactobacillus, New Drug Submission. 28 January 2019
Pharmaceutical
Germany’s Origenis has entered into a global license and collaboration agreement with Expansion Therapeutics to research and discover small molecule compounds targeting RNA-mediated diseases. 25 January 2019
Pharmaceutical
Vertex Pharmaceuticals has fired its chief operating officer and interim chief financial officer Ian Smith, with immediate effect, due to “personal behavior that violated Vertex’s code of conduct and values.” 24 January 2019
Pharmaceutical
Nippon Shinyaku has inked a co-promotion agreement with Johnson & Johnson’s pharmaceuticals arm, Janssen, related to Erleada (apalutamide), a novel oral androgen receptor inhibitor. 22 January 2019
Pharmaceutical
Full mergers and acquisitions in the pharmaceutical and biotechnology in 2024 fluctuated throughout the year with hardly any in some months and a significant number in other. But one thing was clear – buyers were shying away from big bets on commercially ready medicines in favor of earlier stage drug developers. 3 January 2025
Pharmaceutical
Regeneron Pharmaceuticals has acquired UK-based biotech Oxular, enhancing its gene therapy development program with the firm’s specialized ocular delivery tech. 3 January 2025
Pharmaceutical
One of the most promising areas of medical innovation in the next five years is immuno-oncology (I-O)/cancer therapeutics represent, fundamentally transforming how cancer is treated. 3 January 2025
Pharmaceutical
Massachusetts, USA-based based brain disease biotech Neumora Therapeutics shares tumbled 81.4% to 1.97 after it revealed that its experimental depression treatment failed in the first of three studies planned by the biotech company. 3 January 2025
Pharmaceutical
Hutchmed has announced agreements to divest its 45% equity stake in Shanghai Hutchison Pharmaceuticals Limited (SHPL) for $608 million in cash. The buyers are GP Health Service Capital and Shanghai Pharmaceuticals. 2 January 2025
Pharmaceutical
Kazia Therapeutics, an oncology-focused Australian drug developer, has been advised by the US Food and Drug Administration (FDA) that accelerated approval for its brain cancer drug, paxalisib, is unlikely. 2 January 2025
Pharmaceutical
The type 1 diabetes (T1D) market across the seven major markets (7MM: USA, France, Germany, Italy, Spain, the UK, and Japan) is set to grow at a compound annual growth rate (CAGR) of 13.3% from $2.2 billion in 2023 to $9.9 billion in 2033. 2 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib. 2 January 2025
Pharmaceutical
The new $2,000 cap on out-of-pocket costs for prescription drugs went into effect as of January 1, 2025, the US Department of Health and Human Services (HHS) Secretary Xavier Becerra has announced. 2 January 2025
Pharmaceutical
The market for artificial intelligence (AI) in cancer care is projected to grow from $2.2 billion in 2024 to $6.3 billion by 2029, reflecting a growth rate of 23.1%, according to a recent study by BCC Research. 31 December 2024
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Winrevair (sotatercept) to treat pulmonary arterial hypertension (PAH), from US pharma giant Merck & Co. 31 December 2024
Pharmaceutical
US CNS specialist Axsome Therapeutics yesterday announced the completion of its Phase III clinical program evaluating AXS-05 (dextromethorphan-bupropion). 31 December 2024
Pharmaceutical
It has been a year since the launch of Zepbound (tirzepatide) for obesity, and US pharma major Eli Lilly’s competition with Denmark’s Novo Nordisk continues. 31 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) is reopening the comment period for the Federal Register notice (FRN), “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments” due to high interest from industry. 31 December 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning urging the public to avoid purchasing weight-loss medicines without a prescription. 30 December 2024
Pharmaceutical
For many in the life sciences, the year gone by has been marked by volatility across a range of metrics, as political and economic disruptions threaten to upend the standard operating model. 30 December 2024
Pharmaceutical
China’s National Medical Products Administration (NMPA) has recently approved Zorifer (zorifertinib), an oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) specifically for the treatment of non-small cell lung cancer (NSCLC) with CNS metastases. 30 December 2024
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) in patients with agammaglobulinemia or hypogammaglobulinemia disorders, from domestic drug giant Takeda Pharma 27 December 2024
Pharmaceutical
Japanese drugmaker Kaken Pharmaceutical has entered into a license agreement with US healthcare giant Johnson & Johnson for the global development, manufacturing and commercialization of a STAT6 program that Kaken is developing. 27 December 2024
Pharmaceutical
Akums, India’s largest contract development and manufacturing organization (CDMO), has signed a strategic agreement with an undisclosed global pharmaceutical company. 27 December 2024
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