3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
Some more essential drugs to treat cancer, malaria and epilepsy have been brought under price revision and, in certain cases, price control by the Indian government. The move has not gone down well with pharmaceutical companies, reports The Pharma Letter’s India correspondent. 21 September 2016
The European Commission has approved under the EU Merger Regulation the acquisition of Anda Distribution of the USA by Teva Pharmaceutical Industries (NYSE: TEVA) of Israel. 15 September 2016
A new US Government Accountability Office (GAO) report finds that prices for generic drugs in Medicare Part D fell 59% from the first quarter of 2010 to the second quarter of 2015. 14 September 2016
On September 8, 2016, Taro Pharmaceuticals USA Inc, as well as two senior officers in its commercial team, received grand jury subpoenas from the US Department of Justice, Antitrust Division, the Israel-headquartered company revealed in a Securities and Exchange Commission filing. 12 September 2016
Contract development and manufacturing organization (CDMO) Saneca Pharma is investing heavily in its active pharmaceutical ingredients (API) capabilities to support client demand for smaller batch sizes and streamlined scale-up. 12 September 2016
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has come out in support of the Danish company, saying it regrets the General Court (GC) of the European Union’s decision to uphold the European Commission’s classification of the Lundbeck patent settlement agreements as restrictions of competition “by object” thereby judging them to be unlawful. 9 September 2016
Following a public comment period, the US Federal Trade Commission has approved a final order settling charges that Netherlands-incorporated drugmaker Mylan’s $7.2 billion acquisition of Swedish drugmaker Meda would likely be anticompetitive. 9 September 2016
The General Court of the European Union has upheld a 2013 decision to fine the Danish central nervous system specialist Lundbeck for violating competition law over its anti-depressant drug Cipramil (citalopram). 8 September 2016
US biotech Q BioMed has bought the rights to the US Food and Drug Administration-approved drug strontium chloride (SR89) with the promise to keep prices down. 8 September 2016
Turkish drugmaker Abdi İbrahim is to press ahead with two major manufacturing projects at its Istanbul site this year because it sees it as crucial to be ‘bolder in investment’ for the sake of the country’s future. 6 September 2016
Alvogen said today it has launched Remurel (glatiramer acetate), the first generic equivalent of Copaxone, Teva Pharmaceutical Industries’ blockbuster multiple sclerosis drug, in Central and Eastern Europe. 5 September 2016
Netherlands-incorporated Mylan has received another boost in its aim to market a generic version of Teva Pharmaceutical Industries' multiple sclerosis (MS) treatment Copaxone (glatiramer acetate) 40 mg/mL. 2 September 2016
Ireland-incorporated Allergan and its partner Adamas Pharmaceuticals have come to a settlement with privately-held US generics drugmaker Amneal Pharmaceuticals over a copy of Alzheimer’s disease drug Namzaric (memantine and donepezil hydrochloride). 31 August 2016
New data shows that the rate of treatment persistence for patients using the AirFluSal Forspiro respiratory inhaler, developed by Swiss pharma giant Novartis’ generics and biosimilar division Sandoz, is more than twice as high as for the reference product. 31 August 2016
US specialty pharma company Elite Pharmaceuticals saw its shares leap 14.5% to $0.19 after it announced a deal with generic drugmaker SunGen Pharma. 30 August 2016
Mylan has said it will launch the first generic to EpiPen Auto-Injector (epinephrine injection, USP) at a list price of $300 per generic EpiPen two-pack carton. 29 August 2016
The supervisory board of German generic drugmaker Stada Arzneimittel (SAZ: Xetra) on Saturday elected Carl-Ferdinand Oetker as new chairman of the board. 29 August 2016
US drugmaker Upsher-Smith has entered into an exclusive agreement with an emerging pharmaceutical company to market and distribute a generic central nervous system (CNS) product with US sales of more than $200 million for the 12 months ending June 2016, according to IMS Health. 26 August 2016
The US Patent and Trademark Office (PTO) has ruled in favor of Netherlands-incorporated Mylan by invalidating two of Teva Pharmaceutical Industries' patents for the multiple sclerosis (MS) treatment Copaxone (glatiramer acetate). 25 August 2016
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
US antivirals giant Gilead Sciences today announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six generic drugmakers to make and sell generic lenacapavir 2 October 2024
The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. 2 October 2024
The number of clinical trials of new drugs in Russia is steadily declining, which could be mainly related with the overall reduction of investment activities in the local pharmaceutical market, reports The Pharma Letter’s local correspondent. 30 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. 13 September 2024
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
A significant drop has been noticed in the prices of active pharmaceutical ingredients (APIs), bringing much-needed relief to the pharmaceutical industry and potentially translating to lower drug costs for consumers. 9 September 2024
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
German generics major STADA Arzneimittel today announced that it achieved sales of more than 2 billion euros ($2.23 billion) in the first half of 2024. 28 August 2024
In a major crackdown, the Indian government has imposed an immediate ban on 156 fixed-dose combination (FDC) drugs, including commonly used antibiotics, pain relievers,and multivitamins. 27 August 2024
Swipha, a leading Nigerian pharmaceutical manufacturer, has received prequalification from the World Health Organization (WHO) for its sulfadoxine-pyrimethamine (SP) drug. 21 August 2024
One of the largest pharmaceutical production facilities in the Russian North-West region will soon be built in the city of Pushkino by the local drugmaker Active Component enterprise, The Pharma Letter’s local correspondent reports. 14 August 2024
Even as Novartis (NOVN: VX) is locked in a high-stakes battle with the US Food and Drug Administration (FDA) to protect its blockbuster heart failure drug Entresto (sacubitril and valsartan) from generic competition, generic versions of valsartan are making hay in India 8 August 2024
The Russian Ministry of Health has registered the third Russian generic of the original drug Ozempic (semaglutide) from Danish drugmaker Novo Nordisk. 8 August 2024
US biotech major Biogen is disputing the launch of a Russian generic of Spinraza (nusinersen), a drug, which is used to treat spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent. 7 August 2024
Imports of bulk drugs from China have jumped, potentially undermining India's efforts to boost domestic pharmaceutical manufacturing through its Production Linked Incentive (PLI) scheme. 5 August 2024
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A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.