23 September 2024 The Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance.
The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
The Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance. 23 September 2024
German privately-held biotech ARTCLINE Bio-Therapies today announced the appointment of Dirk Hessel as additional managing director of the company. 23 September 2024
Israeli drugmaker Teva Pharmaceuticals has announced new findings from research that could shape treatment strategies in schizophrenia and tardive dyskinesia (TD). 23 September 2024
The H5N1 virus, known for its 50% human case fatality rate, has persisted globally for over two decades, causing thousands of infections. 23 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The US Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). 23 September 2024
Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize Zerviate (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. 23 September 2024
British biotech Vicebio has secured $100 million in a series B funding round to accelerate the development of its next-generation vaccines against respiratory viruses. 23 September 2024
Shanghai-based Fosun Pharmaceutical has announced it has acquired the remaining 50% stake in Fosun Kite Biotechnology from Kite Pharma for $27 million, giving it full control of the joint venture. 23 September 2024
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 September 2024
The Health Sciences Authority (HSA) of Singapore has approved Merck & Co’s Winrevair (sotatercept), for the treatment of adults with pulmonary arterial hypertension (PAH). 23 September 2024
Presentations at the European Society for Medical Oncology (ESMO) Congress in Spain were a major feature of research news last week, including those from Pfizer on it ponsegromab in cancer cachexia, a life-threatening wasting condition in cancer patients. Belgo-American drug developer iTeos Therapeutics announced mixed data at ESMO on its anti-TIGIT belrestotug, under development with UK pharma major GSK. Also of note, Germany’s BioNTech presented mid-stage at ESMO for its BNT327 in lung cancer. In other significant developments, Organon announced it is acquiring Roivant Sciences subsidiary Dermavant for up to $1.2 billion, but only $175 million upfront. Denmark’s Novo Nordisk released Phase IIa results for its recently-acquired obesity candidate monlunabant. 22 September 2024
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
US health technology assessor the Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of two gene therapies intended for the treatment of hemophilia A and B. 22 December 2022
While the vast majority of M&A deals announced so far this year are in the hundreds of million dollars, licensing agreements have been getting ever bigger. 22 December 2022
Bayer subsidiary Asklepios BioPharmaceutical (AskBio) has drawn attention to the role of its own adeno-associated virus technology in all US Food and Drug Administration-approved gene therapies of this type. 22 December 2022
Indian generics major Zydus Lifesciences, formerly known as Cadila Healthcare, subsidiary Zydus Worldwide has received final approval from the US Food and Drug Administration (FDA) to market Selexipag Tablets, 200mcg, 400mcg, 600mcg, 800mcg, 1,000mcg, 1,200mcg, 1,400mcg, and 1,600mcg. 22 December 2022
In a filing with the US Securities and Exchange Commission (SEC), NGM Biopharmaceuticals has revealed its partner Merck & Co will pass on development of ophthalmic products. 22 December 2022
Roche company Genentech has won US approval for its intravenous Actemra (tocilizumab) product, for adults that have been hospitalized with COVID-19. 22 December 2022
US mRNA biotech Moderna, flush with cash due to the success of its COVID-19 vaccine Spikevax, today announced finalizing a strategic partnership with the UK government to establish a state-of-the-art mRNA research, development, and manufacturing facility in the UK. This milestone follows the agreement in principle between Moderna and the UK government, announced in June 2022. 22 December 2022
New gonadotropin-releasing hormone (GnRH) receptor antagonists being introduced to the endometriosis market, will push the sector’s value up from $1.05 billion in 2020 to $2.72 billion in 2030 across the seven major markets (7MM: the USA, 5EU [France, Germany, Italy, Spain, and the UK], and Japan). 22 December 2022
The European Commission has published a study examining the public procurement practices and their impact on medicines supply and availability. The study confirms that awarding multiple winners and using additional criteria other than price (most economically advantageous tender – MEAT criteria) would be more sustainable procurement. 22 December 2022
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Sanofi’s SARS-CoV-2 spike protein (B.1.351 strain) vaccine for the prevention of COVID-19 disease in adults in Great Britain. 21 December 2022
Canada’s Zymeworks saw its shares leap 17% $8.28 today, after it revealed that Jazz Pharmaceuticals has exercised its option to continue with its exclusive development and commercialization rights to Zymeworks' zanidatamab in key markets, including the USA, Europe and Japan, under the license and collaboration agreement the drugmakers entered into in October this year. 21 December 2022
Months after estimating that a fair US price for Pfizer’s Paxlovid (nirmatrelvir/ritonavir) would be between $3,600 and $5,800, the Institute for Clinical and Economic Review (ICER) has drastically changed its view. 21 December 2022
Respiratory disease specialist Verona Pharma has seen its shares jump from around $13 to $18 following positive results from the Phase III ENHANCE-1 trial. 21 December 2022
US clinical-stage biotech Magenta Therapeutics has halted dosing in one of the groups taking part in a Phase I/II study of cancer candidate MGTA-117. 21 December 2022
UK pharma major AstraZeneca today announced two approvals from the European Commission for expanded indications for its blockbuster cancer drugs, one for Imfinzi (durvalumab) and the other for Lynparza (olaparib). 21 December 2022
The volume of drug production in Russia is steadily growing this year despite the ever-tightening sanctions regime and international isolation of Russia, according to recent statements by some leading local pharma analysts and the Russian media, reports The Parma Letter’s local correspondent. 21 December 2022
Danish allergy immunotherapy specialist ALK Abello today announced that Dr Henriette Mersebach will join the company as executive vice president, research and development and member of the board of management. 21 December 2022
The European Commission (EC) has granted conditional marketing authorization for the use of Zynlonta (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Swedish Orphan Biovitrum, also known as Sobi, and Switzerland’s ADC Therapeutics announced today. 21 December 2022
Russian patients with Parkinson's disease have faced a shortage of life-saving drugs based on levodopa, as, according to latest data of the Russian analyst agency RNC Pharma, the supply of these drugs has decreased by 49% in a year. 21 December 2022
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"IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics."