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.
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
Netherlands-based Centrient Pharmaceuticals has announced that the Delhi High Court in India has granted an injunction against Sinopharm Weiqida Pharmaceuticals and Sinopharm India, restricting the export and/or import into India of its active pharmaceutical ingredient (API) amoxicillin trihydrate. 19 February 2019
US drugmaker Abbott says it will expand its Russian production in the Vladimir region this year by the commissioning of two new lines for the production of hospital drugs and the xylene nasal drops, according to an official spokesman of the Vladimir authorities, reports The Pharma Letter’s local correspondent. 19 February 2019
As with most regulations, there are those who think they are a good idea and those that believe otherwise, as has happened with the latest European pronouncement on pharmaceuticals. 14 February 2019
Talk of innovating in pharma normally centers on drug discovery and development, but what about innovation in manufacturing and its ability to improve product quality and drive down costs? 14 February 2019
Israel-based generics giant Teva Pharmaceutical Industries today posted 2018 financial results, showing that full year revenue came in at $18.85 billion, a decrease of 16% in both US dollar and local currency terms, compared to 2017. 13 February 2019
Privately-owned US drugmaker Alvogen has announced the launch of the first generic equivalent of Revlimid (lenalidomide) in a range of its operating central and eastern Europe (CEE) markets including Romania, Croatia, Bulgaria and the Baltic states. 12 February 2019
The US Food and Drug Administration is ensuring that action follows its promises on making life easier for companies making generics to bring costs down in the USA’s health system. 8 February 2019
As of tomorrow (February 9, 2019), most prescription medicines and some over-the-counter medicines for human use supplied in the European Union are required to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging. 8 February 2019
Ireland-incorporated drugmaker Endo International has announced that the US Food and Drug Administration (FDA) has requested a further stay of Endo's ongoing litigation against the FDA through March 15. 7 February 2019
Changes to a law that prevents generics and biosimilar manufacturers in Europe from having the same rights as those outside the continent must not be held up by the vested interests of those from elsewhere in the world. 7 February 2019
London-listed addiction specialist Indivior failed in its bid to block a generic competitor to its Suboxone film drug, used in the treatment of opioid addiction. 6 February 2019
Scott Gottlieb, the Commissioner of the US Food and Drug Administration (FDA), is not satisfied with the progress his agency has already made under his leadership in creating greater competition in the pharma market. 31 January 2019
Netherlands-incorporated Mylan’s shares were up more than 7% at $38.82 by market close on Wednesday, following the news that the US Food and Drug Administration had finally approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder). 31 January 2019
Medicines for Europe welcomes the publication of the European Commission Report on Competition Enforcement in the Pharmaceutical Sector (2009-2017). 29 January 2019
Italian active pharmaceutical ingredients (API) contract development and manufacturing organization (CDMO) Olon SpA and generics supplier, today announced the acquisition of Capua BioServices SpA, a global provider of CDMO services in the field of microbial fermentation. 25 January 2019
India’s Caplin Point Laboratories today announced a 2.18 billion rupees ($30.7million) investment in its injectables subsidiary, Caplin Steriles, by Eight Roads Ventures. 21 January 2019
The Indian Union Health Ministry has banned 80 more fixed-dose combination (FDC) drugs which include antibiotics, painkillers, and medicines used for treating hypertension and anxiety, reports The Pharma Letter’s India correspondent. 19 January 2019
The US Food and Drug Administration (FDA) approved the first generic version of Sabril (vigabatrin) Tablets manufactured by Teva Pharmaceutical Industries US subsidiary, for treating complex partial seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments. 17 January 2019
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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.