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.
The India Brand Equity foundation (IBEF) and the Pharmaceuticals Export Promotion Council (PHARMEXCIL) have provided an update on the country’s generics market as the world’s pharma industry meets for its annual exposition at CPhI Worldview in Frankfurt, Germany. 24 October 2017
Novartis’ closure of a manufacturing unit in Broomfield, Colorado, is due to wider pressures affecting sales of its generics in the USA, the Swiss pharma giant has said. 19 October 2017
The GP Laboratories, a supplier of UK licensed branded and generic pharmaceuticals, has announced its plans to establish a high-tech production of new drugs for the treatment of oncological and other diseases in Russia. 18 October 2017
Shares of specialty pharma firm BioDelivery Sciences International were up mid-morning, after it announced that it has entered into a Settlement Agreement over its opioid dependence treatment. 12 October 2017
Denmark-based Xellia Pharmaceuticals, a specialty pharmaceutical company focusing on providing important anti-infective treatments against serious and often life-threatening infections, has held an official ground breaking ceremony for a new $25 million expansion at its Copenhagen site. 11 October 2017
Piramal Pharma Solutions says it plans to invest $55 million across its sites in North America and Asia, to expand its active pharmaceutical ingredients (API) manufacturing capabilities and capacities. 10 October 2017
The chances of US pharma major Eli Lilly hanging onto market exclusivity with its chemotherapy drug Alimta (pemetrexed for injection) until 2022 were given a fresh boost on Thursday. 6 October 2017
Two companies have been granted approval for the copycat versions of the Teva Pharmaceutical Industries (NYSE: TEVA) multiple sclerosis drug Copaxone (glatiramer acetate) 40mg/mL in Europe. 5 October 2017
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has made his support for increasing the availability of generic drugs very clear since assuming office in May. 5 October 2017
There have been some challenging days in the recent history of Teva Pharmaceutical Industries, and Wednesday would certainly come into that category. 5 October 2017
Market activity on Wednesday underlined the importance of a US Food and Drug Administration (FDA) approval of a generic drug from Mylan. 4 October 2017
The Indian unit of beleaguered Netherlands-incorporated drugmaker Mylan has reached an agreement with Natsimbio, Russia’s leading producer of vaccines, on the supplies of its active substances for the production of anti-HIV drugs in Russia, according to the companies. 28 September 2017
Privately-held South African pharma company Pharma Dynamics has warned of the risk of of ‘pseudo-generics’ in the local pharmaceutical market. 14 September 2017
British drugmaker AstraZeneca has sold the remaining rights to its anesthetics division to Aspen Pharma, a South African firm with a $10 billion market cap. 14 September 2017
Yesterday, in opposition proceedings filed by inter alia Synthon, the Technical Board of Appeal (TBA) of the European Patent Office revoked the last of Teva Pharmaceutical Industries' (NYSE: TEVA) three glatiramer so-called HBr patents which claimed an allegedly improved process for the synthesis of glatiramer acetate. 13 September 2017
Danish CNS specialist Lundbeck saw its shares drop 11.58% to 364.20 Danish kroner this morning, when it was revealed that its chief executive Kåre Schultz is set to join Israeli generics behemoth Teva Pharmaceutical Industries as the latter’s president and CEO. 11 September 2017
Biocon’s subsidiary in Malaysia, Biocon Sdn Bhd, has been issued a certificate of ´GMP Compliance´ for its insulins manufacturing facility by the HPRA (Ireland) as the representative European Union inspection authority. 8 September 2017
Genentech, a subsidiary of Swiss pharma giant Roche, is voluntarily recalling three lots of Activase (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. 8 September 2017
A new study “Value Added Medicines: Time to Adjust the HTA Decision Frameworks” was launched today in Brussels with the support of the Value Added Medicines Group, a sector group of Medicines for Europe. 6 September 2017
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.