Search Results for “EC” – Page 338 – media

Jazz Inks $770M Deal with GSK Spinout Autifony, Nabs Two Neuro Assets

By Tyler Patchen Pictured: A neurosurgeon analyzes an MRI/iStock, gorodenkoff GSK spinout Autifony Therapeutics has entered into an exclusive global licensing deal potentially worth $770.5 million with Jazz Pharmaceuticals for two different ion channel targets associated with neurological disorders. Under the deal announced on Tuesday, the U.K.-based biotech Autifony will receive an undisclosed upfront payment from Jazz and is eligible to receive development, regulatory and commercial milestone payments as well as royalties on any future net sales. Autifony, which is focused on developing treatments for central nervous system disorders and other brain diseases, will spearhead the drug discovery and the preclinical development of the two ion channel targets. Prior to the completion of preclinical development, Jazz will take over clinical development and assume responsibility for manufacturing, regulatory actions and commercialization. “Jazz has an exceptional track record of rapidly advancing neuroscience development programs and effectively commercializing novel therapies that offer improvements ...
- Source: drugdu
- 113
- November 16, 2023
It Will Take More Than Government Regulation of Pharmacy Benefit Managers to Lower Drug Costs

Don Tracy, Associate Editor Proposed legislation aims to address pharmacy benefit manager tactics to reduce prescription drug prices. This year has seen a renewed push by Congress on efforts aimed at regulating the practices of pharmacy benefit managers (PBMs). Currently proposed legislation addresses issues such as the impact of PBMs on patient costs, perverse incentives favoring high-priced drugs, and a greater need for transparency. Currently, PBMs act as intermediaries, managing prescription drug claims and establishing formularies on behalf of insurers, contracting with networks of pharmacies, and negotiating rebates from drug manufacturers. As the authors of a commentary recently published by The New England Journal of Medicine (NEJM) note, PBMs have a significant impact on patient premiums and out-of-pocket costs for prescription medications. “PBMs help control costs by designing formularies that steer patients toward using lower-priced medications and by negotiating lower costs with drug manufacturers in exchange for offering preferred formulary ...
- Source: drugdu
- 187
- November 16, 2023
Pfizer’s cost-cutting campaign hits Sandwich site in UK, where 500 workers will lose jobs

Earlier this month, Pfizer’s $3.5 billion cost-cutting campaign crossed overseas to Ireland. Now, just a week later, Pfizer is announcing hundreds more job cuts in the U.K. Pfizer plans to cut approximately 500 roles and ax its Pharmaceutical Sciences Small Molecule (PSSM) capabilities at its site in Sandwich in Kent in the U.K., a company spokesperson confirmed over email. The spokesperson described the layoffs as a “one of the consequences” of Pfizer’s enterprisewide cost realignment program, which the drugmaker unveiled in mid-October. Under the current plan, the Sandwich site isn’t closing, and other functions will continue “with a different size,” the spokesperson added. Currently, around 940 people are employed at the facility. Local news outlet Kent Online earlier reported that Pfizer was proposing to discontinue all lab and manufacturing work at the Sandwich site.The site is the location where Pfizer scientists first discovered Viagra. During the pandemic, Pfizer invested 10 ...
- Source: drugdu
- 171
- November 16, 2023
Orphelia pushes boundaries with regulatory barriers for pediatric indications

Orphelia Pharma is taking action to drive regulatory agencies like the European Commission to adapt pharmaceutical legislations that would facilitate the development of rare disease pediatric drugs, like the company’s Kizfizo (Ped-TMZ). Kizfizo, a temozolomide biosimilar, is the first oral liquid suspension of temozolomide designed to act as a monotherapy or as a Kizfizo/DNA topoisomerase inhibitor combination treatment for the treatment of relapsed or refractory (r/r) neuroblastoma. Originally indicated exclusively for the treatment of glioblastoma in adults in the US, temozolomide has been used off label to treat r/r neuroblastoma patients for years. The drug is approved for treating GBM in adults and children in Europe. Use of temozolomide in this manner, especially in children, has its drawbacks because children end up being underdosed, executive chairman Giles Alberici told Pharmaceutical Technology. “You often open the capsules and put that in your water. And this is something that should not be ...
- Source: drugdu
- 90
- November 16, 2023
Sandoz opens new antibiotic and biosimilar facilities in Austria and Germany

Antimicrobial resistance is considered one of the top ten global public health threats Sandoz has announced the opening of two new European facilities in Austria and Germany to strengthen the development and supply of critical medicines in the EU and beyond. The two facilities include a new facility for the production of penicillin at Kundl, Austria, along with a new biosimilar development centre in Holzkirchen, Germany. Both facilities align with Sandoz’s commitment to ensuring sustainable access to quality antibiotics as well as spearheading the development of biosimilars. Antibiotics are used to treat or prevent some types of bacterial infections by killing or stopping them from spreading. Antimicrobial resistance has been declared one of the top ten global public health threats facing humanity by the World Health Organization. Currently, penicillin antibiotics are the leading category of antibiotics worldwide. Sandoz’s new penicillin production process aims to improve its ecological footprint and will ...
- Source: drugdu
- 99
- November 16, 2023
Takeda’s enzyme replacement therapy approved by FDA for rare blood clotting disorder

Takeda’s Adzynma (ADAMTS13, recombinant-krhn) has been approved by the US Food and Drug Administration (FDA) as the first therapeutic option for congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare inherited blood clotting disorder. Estimated to affect fewer than 1,000 people in the US, cTTP is caused by a deficiency in the ADAMTS13 enzyme that regulates blood clotting. Patients with cTTP can experience severe bleeding episodes, strokes and damage to vital organs, and mortality rates are high if left untreated. “Without treatment, cTTP is ultimately fatal,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He continued: “[The] approval reflects important progress in the development of much-needed treatment options for patients affected by this life-threatening disorder.” Until now, cTTP treatment has typically involved plasma therapy, which Takeda has previously described as “insufficient in restoring ADAMTS13, time-consuming and costly”. Adzynma, which has been authorised for use as a preventative ...
- Source: drugdu
- 93
- November 16, 2023
Henry Schein says customer data breached in cyber incident

Dive Brief Henry Schein, a medical and dental supplies company, is still recovering from a cybersecurity incident last month that took some of its systems offline. In a letter to its customers, the company disclosed on Monday that a data breach occurred, but “we do not have all the details of what data may have been compromised.” Customer bank accounts and credit card numbers may have been affected. Henry Shein also issued a letter to its suppliers, writing that the company is “aware that the bank account information for a limited number of suppliers was misused.” CEO Stanley Bergman told investors on a Monday earnings call that the company is working to bring its e-commerce platform back online this week, and that the incident primarily affected its dental and medical distribution operations in North America and Europe. Dive Insight Henry Schein lowered its sales expectations for its 2023 fiscal year, ...
- Source: drugdu
- 97
- November 15, 2023
Victoria Atkins MP takes over UK’s department of Health and Social Care

The UK Prime Minister, Rishi Sunak, has confirmed that Victoria Atkins has been appointed Secretary of State for Health and Social Care amid a cabinet shake-up. The Conservative MP for Louth & Horncastle was appointed to the position today (13 November) during a cabinet reshuffle that saw the previous incumbent, Steve Barclay, removed from his position. From 2017 to 2021 Victoria Atkins was the Parliamentary Under Secretary of State for Crime, Safeguarding and Vulnerability at the Home Office, and then moved on to become Financial Secretary to the Treasury between 27 October and 13 November 2022. Initially a barrister by trade and with no formal background in the healthcare trade, her husband Paul Kenward is Managing Director of British Sugar, a firm licensed to grow cannabis for use in children’s epilepsy medication. Now, Atkins will have to helm the government department as it navigates a winter of disruption and potential ...
- Source: drugdu
- 90
- November 15, 2023
New hope for TB patients as UNITE4TB launches clinical trial program

Today, UNITE4TB, an international public-private partnership striving to fast-track the development of innovative Tuberculosis (TB) treatments, announced the start of its phase 2B/C clinical trial program with the first participant enrolled at its trial site in Cape Town, South Africa. The announcement is a major milestone for the project and the TB community as a whole, helping to advance TB science and enhance the efficiency with which new treatments are delivered. The TB challenge TB is a major threat to public health, being among the leading causes of death worldwide. In 2021, the disease claimed the lives of 1.6 million people, making it the second leading infectious killer after COVID-19. Drug-resistant TB and long treatment regimens have increased the urgency for action and investment in TB research. For people affected by TB, the most important outcome is rapid access to better regimens of shorter treatment duration and with fewer side ...
- Source: drugdu
- 96
- November 14, 2023
Optum Rx Moves Eight Preferred Insulin Products to Lowest Cost Tier

Eight rapid-, short-, and long-acting insulin products will move to tier one preferred status, which limits out-of-pocket spending to $35 or less for patients with diabetes. Optum Rx, the pharmacy benefit manager unit of UnitedHealth, announced that it is moving eight rapid-, short-, and long-acting insulin products to tier one preferred status, which offers the lowest cash price that consumers pay.1 The move, which goes into effect on January 1, 2024, will limit out-of-pocket spending to $35 or less for insulin product for patients with diabetes. Image credit: Aleksandra Gigowska | stock.adobe.com “I’ve seen firsthand how high prices for insulin and other necessary medications can cause patients to limit or skip doses,” said Patrick Conway, MD, MSc, chief executive officer of Optum Rx, in a press release.1 “Medicine that people can’t afford is useless, and by taking this important next step to change our formulary, we will lower costs and ...
- Source: drugdu
- 93
- November 14, 2023

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