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.
Ireland headquartered Horizon Pharma has entered into a settlement and license agreement with Perrigo and its subsidiary Paddock Laboratories to resolve pending patent litigation involving Pennsaid (diclofenac sodium topical solution) 2%. 8 May 2015
Ireland-headquartered generics major Actavis yesterday said that it will immediately re-launch its generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) following a decision from the US Court of Appeals. 8 May 2015
Germany-based BASF says it plans to focus its pharmaceutical ingredients and services business within the Nutrition & Health division on its core expertise in pharmaceutical excipients. 7 May 2015
Israeli generics giant Teva Pharmaceutical Industries has reported that first-quarter 2015 revenues amounted to $5.0 billion, in line with revenues in the like 2014 period. 1 May 2015
Japanese drug major Eisai has entered into a settlement agreement with Indian drugmaker Glenmark Pharmaceuticals and its US subsidiaries to resolve their patent litigation relating to Eisai's Banzel (rufinamide) in the USA. 1 May 2015
The USA’s Generic Pharmaceutical Association (GPhA) has submitted new comments on the Food and Drug Administration’s Proposed Rule to update generic drug labeling requirements, urging the agency to adopt the joint alternative proposal known as the Expedited Agency Review (EAR), that it has put forward with the Pharmaceutical Research and Manufacturers of America (PhRMA). 29 April 2015
The US Food and Drug Administration yesterday approved the first generic versions of Bristol-Myers Squibb and Japanese drugmaker Otsuka Pharmaceutical’s Abilify (aripiprazole). 29 April 2015
Canadian specialty drugmaker Valeant Pharmaceuticals has reported first-quarter 2015, posting a profit of $73.7 million compared to a loss of $22.6 million last year. 29 April 2015
Mylan has formally rejected the unsolicited $40.1 billion, or $82 per share, 50% each in cash and stock, from Israel-based larger rival Teva Pharmaceutical Industries that was announced earlier this month. 27 April 2015
TWi Pharmaceuticals has entered into a settlement agreement with Takeda Pharmaceuticals to settle and dismiss all outstanding patent litigation related to TWi's generic dexlansoprazole delayed release capsules for oral administration in 30 mg and 60 mg dosage strengths. 27 April 2015
In the three way acquisition battle that unfolded this month, on Friday generics major Mylan launched its formal bid for Ireland-headquartered drugmaker Perrigo with revised financials. 25 April 2015
A total of seven generic drugs were recommended for approval at the April 2015 meeting of the European Medicines agency’s Committee for Medicinal Products for Human Use (CHMP). 25 April 2015
The Russian government plans to provide compensations for the local drugmakers, specializing on the design and production of cheap and middle-priced drugs, which suffered through the current economic crisis in Russia, caused by Western sanctions, according to recent statements of Russia’s Prime Minister Dmitry Medvedev. 24 April 2015
US health care firm Abbott has reported adjusted diluted earnings per share from continuing operations, which excludes specified items, of $0.47 in the first quarter of 2015. 22 April 2015
Ireland-headquartered drugmaker Perrigo has issued a statement rejecting the unsolicited takeover attempt from Netherlands-headquartered generics major Mylan. 22 April 2015
Confirming earlier speculation, Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) has announced an unsolicited takeover bid for US generics major Mylan (Nasdaq: MYL). 21 April 2015
Israel-based Teva Pharmaceutical Industries has agreed a $512 million settlement in a class-action law suit in which a company it owns was accused of delaying the launch of Provigil (modafinil). 21 April 2015
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.