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Pharmaceutical
China’s Luye Pharma today announced that it has entered the final stage of New Drug Application (NDA) submissions for the innovative drug, risperidone extended release microspheres for injection (LY03004), after previous positive pre-NDA meeting with the US Food and Drug Administration and subsequent related procedures. 31 December 2018
Pharmaceutical
US specialty pharma firm Opiant Pharmaceuticals, developing medicines for addictions and drug overdose, has entered into an exclusive global licensing agreement with French major Sanofi for the development and commercialization of the latter’s drinabant for the treatment of acute cannabinoid overdose (ACO). 28 December 2018
Pharmaceutical
The US Food and Drug Administration has approved Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, Haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) for use in children from 6 weeks through 4 years of age (prior to the 5th birthday). 27 December 2018
Pharmaceutical
The US Food and Drug Administration approved calaspargase pegol-mknl, brand name Asparlas, from privately-held French drugmaker Servier. 24 December 2018
Pharmaceutical
The European Commission EC) has approved AstraZeneca’s Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in a pressurised metered-dose inhaler (pMDI) as a maintenance dual bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 21 December 2018
Pharmaceutical
Supernus Pharmaceuticals has announced positive topline results from the Phase III P302 study of SPN-812 in adolescents, for the treatment of attention deficit hyperactivity disorder (ADHD). 21 December 2018
Pharmaceutical
Eli Lilly has provided updated guidance, forecasting revenue and adjusted profit figures for 2019 that are higher than expected. 20 December 2018
Pharmaceutical
H Spectrum, a Taiwan-based healthcare fund backed by Foxconn, have entered into a memorandum of understanding (MOU) with the German life sciences group Merck KGaA to establish H Spectrum & Merck Innovation Lab. 19 December 2018
Pharmaceutical
The US Food and Drug Administration has appointed Amy Abernethy as principal deputy commissioner, replacing Rachel Sherman, who is retiring. 19 December 2018
Pharmaceutical
UK-based Indivior says it will launch an authorized generic of its Suboxone Film (buprenorphine/naloxone) product, once generic competitors enter the market. 19 December 2018
Pharmaceutical
US-based generics firm Sandoz has agreed a deal with Chinese insulin supplier Gan & Lee to produce biosimilar versions of insulins for type 1 and type 2 diabetes. 19 December 2018
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical today announced that the listing and trading of its American Depositary Shares (ADSs) on the New York Stock Exchange is expected to commence on December 24, 2018. 19 December 2018
Pharmaceutical
Horizon Discovery Group has entered into an exclusive target discovery partnership with fellow UK-listed firm C4X Discovery, aimed at delivering potential therapies for colorectal and lung cancer. 18 December 2018
Pharmaceutical
Japan’s Taisho Pharmaceutical is reportedly close to agreeing terms with Bristol-Myers Squibb to acquire the company’s French consumer healthcare unit for around $1.6 billion. 18 December 2018
Pharmaceutical
US pharma giant Merck & Co has reached agreement to acquire privately held Antelliq Group from funds advised by BC Partners. 17 December 2018
Pharmaceutical
Rubella vaccines are being offered for free to middle-aged men in Japan who missed out on immunisations in their childhood. 13 December 2018
Pharmaceutical
Privately-held X-Chem and Spain's Almirall have agreed to enter into a drug discovery partnership looking for lead compounds in dermatology. 13 December 2018
Pharmaceutical
STAT3 inhibitor specialist Tvardi Therapeutics has appointed Imran Alibhai as chief executive. 12 December 2018
Pharmaceutical
Chinese research and development platform company WuXi AppTec has announced the expansion of its facilities in San Diego, California. 11 December 2018
Pharmaceutical
Japanese pairing Shionogi and Ube Industries have agreed to jointly research respiratory syncytial virus (RSV) drug candidates. 10 December 2018
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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