media – Page 418 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

US FTC Requests More Information on Pfizer’s Proposed $43bn Seagen Acquisition

The US Federal Trade Commission (FTC) has requested more information and documentary material regarding Pfizer’s proposed $43bn acquisition of Seagen. The second request is a standard review procedure by which the FTC and the Antitrust Division of the US Department of Justice investigate mergers and acquisitions. If a second request is submitted, the law forbids merging companies from completing a transaction until they have substantially complied with the additional investigatory request. The Pfizer/Seagen agreement, which was originally announced in March this year, would mark a significant boost to the US pharma’s oncology pipeline. At the time of the announcement, Pfizer’s oncology portfolio included 24 approved drugs, while Seagen’s included Adcetris for lymphomas, Padcev for bladder cancers, Tivdak for cervical cancer, and Tukysa for breast and colorectal cancers. The deal would also grant Pfizer access to Seagen’s drug development pipeline as well as its proprietary ...
- Source: drugdu
- 337
- July 21, 2023
Pfizer Group B Strep Vaccine for Infants Returns Encouraging Mid-Stage Trial Results

Pfizer on Wednesday said its experimental vaccine targeting the potentially deadly bacterial disease Group B Streptococcus returned strong mid-stage clinical trial results, a promising step as the drug inches toward potential approval. Pfizer is among several drugmakers racing to develop the world’s first shot targeting Group B strep disease, which is linked to nearly 150,000 infant deaths worldwide each year, especially in lower-income countries. The Food and Drug Administration in September granted breakthrough therapy designation to Pfizer’s vaccine, which is intended to expedite the development and review of the shot. Pfizer’s single-dose shot generated antibodies that may provide infants with meaningful protection against the disease, according to the data released Wednesday from a phase two clinical trial. The jab is administered to expectant mothers, who pass vaccine-induced antibodies to their fetuses. One of the company’s vaccines targeting respiratory syncytial virus also uses that maternal vaccination method. ...
- Source: drugdu
- 160
- July 21, 2023
Pieris Pharma Lays off 70% of Workforce Amid Company Restructuring

Pieris Pharmaceuticals will be laying off 70% of its workforce as part of a corporate restructuring following the termination of its collaboration with British pharmaceutical company AstraZeneca. After encountering challenges such as the termination of patient recruitment in a Phase IIa asthma trial of the drug elarekibep, AstraZeneca decided to end its R&D partnership with Pieris, per the 18 July announcement. The company has returned elakeribep and terminated the existing discovery program. The two companies announced their collaboration to develop inhaled engineered proteins in May 2017. As part of the agreement, AstraZeneca has agreed to fund all clinical development and commercialisation programmes of the lead candidate, elarekibep. Also known as PRS-060, elarekibep is a type of engineered protein that targets interleukin-4 receptor alpha, which is based on Pieris’ Anticalin platform. The companies also agreed to develop four additional treatments based on the platform for different targets ...
- Source: drugdu
- 161
- July 21, 2023
QuidelOrtho Test Could Miss Heart Attacks, Drawing Class I recall

Dive Brief QuidelOrtho’s recall of a test to detect heart attacks was labeled Class I by the Food and Drug Administration, the most serious type of recall, the agency said in a Monday notice. The San Diego-based diagnostic manufacturer flagged a problem with the tests in late May after receiving reports that the tests showed lower than expected troponin levels, which could result in delayed or missed diagnosis of a heart attack. The recall affects nearly 7,800 tests, and QuidelOrtho is instructing clinicians to immediately discontinue using the product, and instead use a different test or send patients to another testing site. Dive Insight Quidel’s Triage Cardiac Panel is intended to help diagnose heart attacks. The test uses a blood sample, and can deliver results in about 20 minutes, according to the company’s website. It is important to detect heart attacks quickly to ...
- Source: drugdu
- 238
- July 20, 2023
EAE Hub Model Reduces Barriers to Early Autism Diagnosis

A new study led by Indiana University School of Medicine researchers shows primary care clinicians who receive specialized training can make accurate autism diagnoses for over 80 percent of young children referred with developmental delays, providing compelling evidence that community-based models of autism evaluation are a potential solution for improving access to this needed service. They recently published their findings in Pediatrics. One in 36 children are now diagnosed with autism, according to the latest 2023 report from the Centers for Disease Control. In many regions of the county, waitlists for autism diagnostic evaluations often exceed a year and families regularly travel long distances to access the limited number of specialists who are qualified to perform these evaluations. Rebecca McNally Keehn (PhD, assistant professor of pediatrics and lead author of the study) said, “The bottleneck families experience in their road to an accurate diagnosis is a public ...
- Source: drugdu
- 263
- July 20, 2023
Johnson & Johnson Becomes 4th Drugmaker to File Suit Against IRA’s Drug Price Negotiations

Johnson & Johnson has hopped on the litigation bandwagon, becoming the fourth large drugmaker to sue the U.S. government over drug price negotiations in the Inflation Reduction Act (IRA).In U.S. District Court in New Jersey, J&J claimed (PDF) that price negotiations by Medicare would violate the First and Fifth Amendments of the U.S. Constitution. Merck, Bristol Myers Squibb and Astellas have made the same argument in separate lawsuits. Last week in federal court in Washington, D.C., Merck applied more pressure, filing for a decision in its case without a trial. The U.S. Chamber of Commerce and industry association PhRMA have also filed suits with similar claims. “The government is forcing (J&J) to provide its innovative, patented medicines on pricing terms that by law must be significantly below market prices,” J&J said in a release. “This would upend the current self-sustaining cycle of pharmaceutical innovation that provides patients with access ...
- Source: drugdu
- 373
- July 20, 2023
EU Prepares for the Winter With Plans to Avoid an Antibiotic Shortage

The European Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) have issued recommendations to prevent shortages of antibiotics. Drug shortages have become the norm in recent years, with the US Food and Drug Administration (FDA) reporting 295 active shortages in the last quarter of 2022 and the EMA reporting that a shortage of cardiovascular medications is expected to continue until next year. The EMA has said that the EU has an adequate supply of oral antibiotics for the treatment of respiratory infections, if the demand remains comparable to previous years, as per a 17 July press release. Nonetheless, the agency has issued several recommendations to ensure robust preparedness. It has also announced plans to engage with marketing authorisation holders to increase production and continue to monitor supply and demand without resorting to stockpiling. In addition, the agency wants to increase ...
- Source: drugdu
- 150
- July 20, 2023
Alnylam Presents Promising Results for RNAi Therapeutic in Alzheimer’s Disease at AAIC

Alnylam Pharmaceuticals’ investigational RNAi therapeutic has shown promise in patients with early-onset Alzheimer’s disease, according to phase 1 results presented by the company at this year’s Alzheimer’s Association International Conference (AAIC). Interim results from the early-stage study showed that a single injection of ALN-APP, which is designed to switch off the production of amyloid precursor protein (APP) in the central nervous system, was able to rapidly reduce levels of the protein, with clinical effect sustained over six months. ALN-APP is being developed in collaboration with Regeneron Pharmaceuticals for both Alzheimer’s disease and the related disorder cerebral amyloid angiopathy (CAA) and is now the first investigational RNAi therapeutic to demonstrate gene silencing in the human brain. “We’ve known for decades that mutations that increase APP production, or alter its proteolysis, cause early-onset Alzheimer’s disease, early-onset CAA or both,” said Dr Sharon Cohen, neurologist and medical director, Toronto ...
- Source: drugdu
- 182
- July 20, 2023
Sanofi and Scribe Announce in Vivo Genetic Therapy Partnership Worth Over $1.2bn

Sanofi and Scribe Therapeutics have announced an expanded collaboration agreement worth over $1.2bn to advance in vivo genetic medicines for sickle cell and other genomic diseases. The agreement follows the launch of the companies’ existing partnership focused on developing ex vivo editing of natural killer cell therapies for cancer. Under the latest deal, Sanofi will gain an exclusive licence to use Scribe’s CRISPR X-Editing genome editing technologies to develop in vivo therapies. In exchange, Scribe will receive a $40m upfront payment and will also be eligible for more than $1.2bn based on the successful completion of certain development and sales milestones. Sanofi will largely be responsible for any resulting candidates, but Scribe will have the opportunity to opt into sharing the development costs and profits on one future programme in the US. Christian Mueller, global head of Genomic Medicine Unit at Sanofi, said: “We’re ...
- Source: drugdu
- 193
- July 20, 2023
Pfizer Inks Potential $7B Deal with Flagship to Deepen Pipeline

Pfizer is looking to enrich its pipeline with up to 10 new innovative medicines by partnering with startup creator Flagship Pioneering, the companies announced Tuesday. Under the terms of the agreement, Pfizer and Flagship will each contribute an upfront investment of $50 million. The collaboration will leverage Flagship’s rich ecosystem of biotechnology platforms and more than 40 human health companies. Pfizer and Flagship will explore up to 10 single-asset programs, which Pfizer will fund and have the option to acquire. Flagship and its companies will be eligible to receive up to $700 million in milestones and royalties for each program that hits the market, giving Tuesday’s deal a maximum potential value of $7 billion. This partnership will bring together expertise from Pfizer and Flagship “to maximize discovery and development potential from inception to impact,” Paul Biondi, executive partner at Flagship and president of Pioneering Medicines, said in a statement. ...
- Source: drugdu
- 171
- July 20, 2023

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