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Generics
The US affiliate of Teva Pharmaceutical Industries announced today the launch of an authorized generic of Victoza (liraglutide injection 1.8mg), in the USA. 24 June 2024
Generics
Danish specialty pharma company Xellia Pharmaceuticals, which is owned by Novo Holdings, today revealed that the US Court has vacated the Modified Consent Decree imposed on Xellia’s Cleveland, Ohio, USA facility in 2016. 29 April 2024
Generics
Swiss generic and biosimilar medicines maker Sandoz today opened a new production facility in Kundl, Austria, to serve more patients with affordable life-saving drugs produced entirely in Europe. 21 March 2024
Generics
Advancing complex generic drug development is a critical part of the US Food and Drug Administration’s (FDA) goal to help patients access safe, effective and high-quality generic medicines, the agency stated. 9 February 2024
Generics
Indian drugmaker Sun Pharmaceutical has increased its bid to acquire Israeli generics firm Taro Pharma, up to $43 per share from its previous offer of $38 per share. 14 December 2023
Generics
Although safety risks for Lotronex (alosetron hydrochloride) and approved generics still exist, the US Food and Drug Administration (FDA) has determined the risk evaluation and mitigation strategy (REMS) for the drugs are no longer necessary to ensure the benefits outweigh the serious risks of ischemic colitis and serious complications of constipation. 9 September 2023
Generics
Privately-held UK headquartered Advanz Pharma has signed an exclusive licensing and supply agreement with GP Pharm for a peptide specialty injectable generic in a rare disease indication for multiple European countries. 4 September 2023
Generics
A California federal jury cleared Gilead Sciences and Teva Pharmaceutical Industries on Friday in a $3.6 billion antitrust case claiming the pharmaceutical giants struck an illegal "pay for delay" patent deal that inflated prices for two HIV medications. 1 July 2023
Generics
Indian drugmaker Lupin Limited has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for tiotropium bromide inhalation powder, 18 mcg/capsule, a generic equivalent of German pharma major Boehringer Ingelheim’s Spiriva HandiHale. 22 June 2023
Generics
Today, the US Food and Drug Administration published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list). 13 June 2023
Generics
Juno Pharmaceuticals Canada has purchased Omega Laboratories, a specialist injectable pharmaceutical manufacturer in Canada, for an undisclosed sum. 19 May 2023
Generics
Japanese drug major Astellas Pharma today confirmed that the US Court of Appeals for the Federal Circuit (CAFC) issued a Mandate that officially ends the CAFC appeal on patent infringement of Lexiscan (regadenoson injection) 0.4mg/mL. 11 May 2023
Generics
RedHill Biopharma has published new data for its antibiotic Talicia (omeprazole/amoxicillin/rifabutin), focused on differentiating the brand from generic alternatives. 10 May 2023
Generics
Indian drugmaker Lupin Limited says it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2mg/mL of Hikma Pharmaceuticals. 9 February 2023
Generics
Japanese drugmaker Chugai Pharmaceuticals, which is majority-owned by Roche, says that the Intellectual Property High Court has rendered judgment to dismiss the plaintiff’s appeal filed on June 9, 2022, regarding generic drugs to an osteoporosis agent, active vitamin D3 derivative Edirol (eldecalcitol) Capsule 0.5µg/0.75µg. 14 December 2022
Generics
The US Food and Drug Administration (FDA) yesterday published the draft guidance for industry, titled “Statistical Approaches to Establishing Bioequivalence,” which provides recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. 3 December 2022
Generics
New Jersey, USA-based Amneal Pharmaceuticals today said it has launched commercial operations in India. 10 October 2022
Generics
The US Food and Drug Administration has published more information related to recent changes to Generic Drug User Fee Amendments (GDUFA). 7 October 2022
Generics
UK provider of niche generic and branded specialty pharmaceuticals Aspire Pharma says it has completed its acquisition of privately-held Morningside Pharmaceuticals (Loughborough), Morningside Healthcare (Leicester) and Morningside Healthcare (India). 3 October 2022
Generics
The Court of Appeals for the Federal Circuit ruled in favor of Merck & Co in a patent challenge brought by Mylan Pharmaceuticals (now Viatris) related to sitagliptin dihydrogen phosphate, an active ingredient in Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride) and Janumet XR (sitagliptin and metformin hydrochloride extended-release). 30 September 2022
Generics
The issue of US drug pricing and what government action might be taken to lower prices are getting as many headlines as ever at the start of 2019, but China is currently providing more striking evidence of action on cutting drugmakers’ margins. 3 January 2019
Generics
Israeli generics giant Teva Pharmaceutical Industrie announced that it has resolved its ongoing dispute with Amgen over Teva’s generic cinacalcet HCl, 3 January 2019
Generics
Ironwood Pharmaceutical and Allergan have reached an agreement with Mylan Pharmaceuticals resolving patent litigations brought in response to Mylan’s Abbreviated New Drug Applications (ANDAs) approval to market generic versions of Linzess (linaclotide) prior to the expiration of the companies’ applicable patents. 3 January 2019
Generics
The US Food and Drug Administration (FDA) has approved Slayback Pharma’s abbreviated new drug application (ANDA) for a generic equivalent of the Makena injection (hydroxyprogesterone caproate) 1,250mg/ 5mL multi-dose vial. 2 January 2019
Generics
Hetero Labs, one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs, today announced that its European subsidiary Amarox has acquired Tarbis Farma. 2 January 2019
Generics
Endo International today announced that, due to the ongoing federal government shutdown, the US Food and Drug Administration has requested a further stay of Endo's ongoing litigation against the FDA for the duration of the shutdown. 31 December 2018
Generics
Teva Pharmaceutical Industries has launched a generic version of Elidel (pimecrolimus) Cream, 1% in the USA. 31 December 2018
Generics
To boost public confidence in generic medicines, India’s drug controller is putting stringent quality control measures in place. 28 December 2018
Generics
Given the ability of Indian pharmaceutical companies to produce drugs at economical rates, the cost of HIV/AIDS treatment has fallen on a global scale to $400 per year from $12,000, according to a senior executive. Noting that a similar initiative was needed to tackle cancer, the executive said more cancer treatment units were needed in rural areas to fight the dreaded disease, reports The Pharma Letter’s India correspondent. 27 December 2018
Generics
Israel-based Teva Pharmaceutical Industries’ application to reopen and modify its decision and order in connection with the 2012 merger of Watson Pharmaceuticals and Actavis has been approved by the US Federal Trade Commission. 19 December 2018
Generics
The US Food and Drug Administration has said it is withdrawing a proposed rule which would have allowed generic drugmakers to independently update and distribute new safety information in drug labels. 14 December 2018
Generics
Activity in the pharma sector is rife in India, with mergers and acquisition deal values doubling given revived domestic and cross-border deal activity. Technology in the form of Artificial Intelligence and Big Data has also come to the aid of the pharmaceutical industry, reports The Pharma Letter’s India correspondent. 12 December 2018
Generics
Fresenius saw its worst share price fall ever on Friday, after the German healthcare group issued a profit warning, the previous day. Its share plunged 17.71% to 38.00 euros by close. 8 December 2018
Generics
German drugmaker Stada Arzneimittel has increased its indirect shareholding in the Vietnamese pharmaceutical company Pymepharco JSC to 72%, in which it has been a strategic since 2008. 7 December 2018
Generics
The US Food and Drug Administration (FDA) has published final guidance for the generics industry on post-complete response letter (CRL) meetings. 4 December 2018
Generics
Medicines for Europe, a group representing the European generic and biosimilar industries, has called on regulators to “make the SPC manufacturing waiver a success for Europe.” 30 November 2018
Generics
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is undertaking a pharmacy level recall of all affected batches of valsartan containing medicines made by Mylan and Teva Pharmaceutical Industries as a precautionary measure. 30 November 2018
Generics
Netherlands-headquartered Mylan’s (Nasdaq: MYL) flagship oral solids facility getting a US Food and Drug Administration warning letter is being viewed as an advantage Indian drug majors, reports The Pharma Letter’s India correspondent. 30 November 2018
Generics
Sumitomo Dainippon Pharma made massive gains in the stock market on Tuesday. 28 November 2018
Generics
Czech Republic-based drugmaker Zentiva and German pharmaceutical trader Phoenix joined forces this week for an inaugural annual partnership meeting in Prague to kick off a strategic partnership between the two healthcare companies in Europe. 23 November 2018
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