Search Results for “EC” – Page 87 – media

BMS sought bogus patents, filed sham lawsuits and more to protect Pomalyst, lawsuit says

After 10 years on the market, the Bristol Myers Squibb and Celgene blockbuster multiple myeloma treatment Pomalyst has landed in some legal hot water.In a new lawsuit (PDF), Blue Cross and Blue Shield of Louisiana claims Celgene used an illegal scheme to protect the drug’s monopoly, causing purchasers to overpay by “hundreds of millions, if not billions” of dollars over the years. BMS did not immediately respond to Fierce Pharma’s request for comment. The company acquired Pomalyst in its $74 billion buyout of Celgene in 2019. In the suit, Blue Cross and Blue Shield of Louisiana says Celgene sought fraudulent patents, abused the federal judicial system and shared some of its “illicitly acquired” profits with generic drug makers to keep competition at bay. Specifically, Celgene knowingly secured certain patents using information that was already in the public domain, Blue Cross argues. To protect these patents, Celgene initiated lawsuits against would-be ...
- Source: drugdu
- 201
- September 9, 2023
Researchers receive $2.5 million award to develop a tailored treatment for glioblastoma

A multidisciplinary team of investigators from the UCLA Jonsson Comprehensive Cancer Center was awarded a $2.5 million Translational Team Science Award from the Department of Defense to develop a tailored treatment for glioblastoma, a deadly brain tumor with limited treatment options. The team -; including David Nathanson, associate professor of molecular and medical pharmacology at the David Geffen School of Medicine at UCLA, Benjamin Ellingson, director of the UCLA Brain Tumor Imaging Laboratory and professor of radiological sciences, and Dr. Timothy Cloughesy, professor of neuro-oncology -; plan to target the epidermal growth factor receptor, a protein that is mutated in about 60% of people diagnosed with glioblastoma. Previous attempts have had limited success improving patient outcomes due to drugs’ inability to cross the blood-brain barrier and target genetic alterations in the protein that are unique to glioblastoma. To overcome these obstacles, the researchers have developed ERAS-801, a brain-penetrant inhibitor that ...
- Source: drugdu
- 107
- September 7, 2023
VGovernment-backed autoinjector specialist AktiVax shutters ‘substantially all of its operations,’ lays off 70

Despite scoring a number of federal contracts in recent years, it’s lights out for government-backed rescue autoinjector maker AktiVax. Late last month, AktiVax, also known as Aktiv Pharma Group, informed the state of Colorado that “the company must shut down substantially all of its operations,” citing “unexpected circumstances.” In turn, the company is mothballing three manufacturing facilities and laying off around 70 employees. The plant closures and layoffs are set to affect a facility in Broomfield, Colorado, plus two sites in Fort Collins, according to a letter sent to a state official. The “entire plants” are to be closed, and AktiVax expects the action will be “permanent.” Jobs that will be affected run the gamut from patent prosecution and purchasing agents to engineers, technicians, quality control microbiologists and human resources executives. AktiVax’s business primarily revolves around its autoinjector ARAI, which the company says is the only autoinjector with single-hand, single-step ...
- Source: drugdu
- 106
- September 7, 2023
Illumina Taps Agilent Exec as New CEO Amid Company’s Daunting Challenges

By Kate Goodwin Pictured: Illumina sign in San Diego/iStock, Georgejason After months of upheaval, Illumina named Jacob Thaysen its new CEO Tuesday, replacing Francis deSouza who stepped down in June after losing a proxy fight with billionaire activist investor Carl Icahn. Thaysen, the former senior vice president of Agilent Technologies and president of its life sciences and applied markets group, will take the reins Sept. 25. He has his work cut out for him. The DNA-sequencing technology company has faced a rocky road since its acquisition agreement with cancer diagnostics maker GRAIL in September 2020. The deal faced scrutiny from both the Federal Trade Commission and the European Commission due to concerns over antitrust laws. In April, activist investor Carl Icahn went after then-CEO Francis deSouza and campaigned to replace three of Illumina’s board members. While his efforts only got him one seat on the board, deSouza did step down ...
- Source: drugdu
- 99
- September 7, 2023
Weight-loss drug firm becomes Europe’s most valuable

By Mariko Oi The maker of weight-loss drug, Wegovy, has become Europe’s most valuable firm dethroning the French luxury conglomerate LVMH. Shares rose after the Danish pharmaceutical giant, Novo Nordisk, launched the popular drug in the UK. At the close of trading on Monday, the firm had a stock market valuation of $428bn (£339bn). The drug is now available in the UK public healthcare system and also on the private market. Wegovy is an obesity treatment that is taken once a week which tricks people into thinking that they are already full, so they end up eating less and losing weight. Famous personalities such as Elon Musk are among the reported users of the drug, which has captivated Hollywood and the public more widely since it was approved by regulators in the US in 2021. Wegovy and Ozempic – a diabetes treatment with similar effects – have been described as ...
- Source: drugdu
- 221
- September 6, 2023
Delaware’s Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

When it comes to heart failure medication, a labeling mix-up can have dire consequences. That’s why Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg doses. The company is pulling the batches of the heart failure medication because certain bottles of 0.125-mg digoxin tablets are mislabeled with the 0.25-mg dose and vice versa. The labeling snafu could cause either overdosing of underdosing in patients who unknowingly take the wrong strength of medication, Marlex warned in a notice posted on the FDA’s website. Patients on 0.125-mg strength digoxin who take the higher dose could experience “significant drug toxicity” such as mental disorientation, dizziness, blurred vision, memory loss and fainting, the company added. Meanwhile, patients who take a subpotent dose may experience loss of control of heart rate and potential heart failure exacerbation, Marlex said. As of Thursday, Marlex said it hadn’t received ...
- Source: drugdu
- 219
- September 6, 2023
Following in Tecentriq’s footsteps, Alecensa gives Roche another win in early-stage lung cancer

After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa. Alecensa, compared with chemotherapy, reduced the risk of tumor recurrence or death when used after surgery in certain non-small cell lung cancer patients, Roche said Friday. The patients had ALK-positive, stage 1b to 3a tumors that were completely resected before taking Alecensa. The positive readout, from the ALINA trial, makes Alecensa the first ALK inhibitor to show a benefit in early-stage NSCLC in a phase 3 trial, Roche noted. Data on patient survival remain immature. But the Swiss pharma said it’ll submit the results to the FDA and the European Medicines Agency for a potential label expansion. “If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure,” Roche’s chief ...
- Source: drugdu
- 113
- September 6, 2023
Respiratory patients are most vulnerable to the effects of climate change

People living with lung conditions, such as asthma and chronic obstructive pulmonary disease (COPD), face even greater risks from climate change, according to an expert report published today (Monday) in the European Respiratory Journal. The report brings together evidence on how the effects of climate change, such as heatwaves, wildfires and flooding, will exacerbate breathing difficulties for millions of people around the world, particularly babies, young children and the elderly. On behalf of the European Respiratory Society, which represents more than 30,000 lung specialists from 160 countries, the authors are calling on the European Parliament and governments around the world to urgently reduce emissions of greenhouse gasses and mitigate effects of climate change. Professor Zorana Jovanovic Andersen, Chair of the European Respiratory Society’s Environment and Health Committee and based at the University of Copenhagen, was an author of the report, ‘Climate change and respiratory health: a European Respiratory Society position ...
- Source: drugdu
- 105
- September 5, 2023
BioNTech, DualityBio Move ADC into Phase III for HER2-Low Breast Cancer

By Kate Goodwin Pictured: 3D rendering of antibody-drug conjugate/iStock, Love Employee BioNTech’s licensed antibody-drug conjugate is moving on to Phase III testing in a potential effort to challenge AstraZeneca and Daiichi Sankyo’s blockbuster Enherto in a heavily treated breast cancer subpopulation. DualityBio, BioNTech’s partner and the ADC’s creator, posted the trial plans Wednesday. BioNTech added the ADC, DB-1303, to its portfolio in April 2023 when it paid China’s DualityBio $170 million upfront for rights to it plus a second preclinical asset. Another $1.5 billion is on the line in milestone payments, plus tiered royalties. DB-1303 will be pitted against chemotherapy in the open-label Phase III for patients with HER2-low, HR+ metastatic breast cancer patients whose disease has progressed despite endocrine therapy. ADC therapy is like a targeted missile for cancer, with an antibody targeted to deliver the cancer killing payload. DB-1303 is a topoisomerase-1 inhibitor. Phase I/II trial results showed ...
- Source: drugdu
- 105
- September 5, 2023
Sage Therapeutics Fires 40% Of Staff after FDA Rejected MDD Bid

Sage Therapeutics will reduce its workforce by 40% following the US Food and Drug Administration’s (FDA) rejection of its drug Zurzuvae (zuranolone) in adults with major depressive disorder (MDD). The US-based company will pause some undisclosed early-stage programs and focus instead on the refinement of its compounds SAGE-718 and SAGE-324, per the 31 August announcement. Sage’s leadership will also change with the departure of the current chief scientific officer (CSO) Al Robichaud and the chief development officer (CDO) Jim Doherty. The restructuring comes at a time when the company plans the commercial launch of Zurzuvae for treating postpartum depression which is expected in late 2023. On 4 August, the FDA approved Zurzuvae’s use in women with postpartum depression while simultaneously issuing a complete response letter (CRL) for the treatment’s use in MDD. The CRL stated that the drug’s application did not provide substantial evidence of effectiveness in MDD and that ...
- Source: drugdu
- 150
- September 5, 2023

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