PharmaFocus Today – Page 317 – media

Labcorp forms spin-off of Fortrea

Labcorp, the laboratory service supplier based in the US, has completed the spin-off of Fortrea, to create the newly formed contract research organisation that will give pharmaceutical and biotechnology organisations access to global Phase I-IV clinical trial management, patient access and technology solutions. Fortrea made a cash distribution of around $1.6bn as partial consideration for the assets that Labcorp contributed to Fortrea in connection with the spin-off. Labcorp will use the distribution toward a $1bn accelerated share repurchase program and pay down $300m of debt maturing this year. Whatever is left of the funds will be distributed among shareholders. The spin-off distribution was completed on 30 June 2023 to stockholders of record as of the close of business on 20 June 2023. Labcorp’s stockholders each received one share of Fortrea common stock for every share of Labcorp common stock they held as of the record date. The spin-off will pass ...
- Source: drugdu
- 115
- July 6, 2023
Regeneron’s high-dose Eylea hit with surprise FDA rejection over manufacturing hiccups

The FDA turned down the closely watched eye med because of manufacturing problems the agency spotted at a third-party drug filler, Regeneron said in a release. The FDA didn’t flag any issues with the med’s efficacy and safety or its labeling and drug substance manufacturing and didn’t request additional clinical data, the company said. In a race against Roche’s Vabysmo, Regeneron and its partner Bayer’s application for the 8 mg Eylea (aflibercept) version was accepted in February, hoping for approval in wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. Despite the hurdle, Regeneron remains “committed to working closely with the FDA and the third-party filler” to introduce the high-dose drug, the company said. A Regeneron spokesperson declined to comment on the identity of the filler or where it’s located. Elsewhere, the FDA recently published a Form 483 against an Eli Lilly plant in Indianapolis after an inspection in ...
- Source: drugdu
- 98
- July 6, 2023
Boehringer’s spesolimab shows promise in generalised pustular psoriasis prevention

Boehringer Ingelheim has shared positive new 48-week data from a phase 2b trial of its anti-interleukin-36 receptor (IL-36R) antibody in patients with generalised pustular psoriasis (GPP). The results from the EFFISAYIL 2 trial, presented by the company at this year’s World Congress of Dermatology, show that spesolimab reduced the risk of GPP flares by 84% over 48 weeks compared to placebo. The trial also demonstrated no flares after week four of spesolimab treatment in the high dose group, Boehringer said. GPP is a rare and chronic neutrophilic skin disease, which is genetically and clinically distinct from plaque psoriasis. GPP is caused by neutrophils – a type of white blood cell – accumulating in the skin, causing painful, sterile pustules all over the body. Despite the varying severity of GPP flares, if left untreated they can be life-threatening due to complications such as sepsis and multisystem organ failure, and the unpredictability ...
- Source: drugdu
- 199
- July 6, 2023
first interchangeable biosimilar to Humira rolls out across US

Boehringer Ingelheim’s new autoinjector pen administering Cyltezo (adalimumab-adbm) is now available to patients living with chronic inflammatory diseases in the US. The Cyltezo pen autoinjector, which is a biosimilar to AbbVie’s blockbuster Humira (adalimumab), received approval from the US Food and Drug Administration (FDA) in May 2023. Boehringer Ingelheim originally received FDA approval for the drug in 2017, and then further approval as an interchangeable biosimilar in 2021. The 40mg/0.8ml pre-filled Cyltezo Pen will be offered in two, four and six-pack options. AbbVie has enjoyed a prosperous monopoly of the adalimumab market with Humira generating $21.2bn in global sales in 2022. With several biosimilars likely to flood the market in 2023 and the company losing exclusivity, AbbVie said it expects its sales of the drug to decline 37% in 2023. Challengers to Humira are now vying for market share. Organon and Samsung Bioepsis launched an autoinjector pen on 1 July, ...
- Source: drugdu
- 135
- July 5, 2023
Zealand Pharma submits NDA for hyperinsulinism drug dasiglucagon

Zealand Pharma has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its treatment dasiglucagon for use in paediatric patients aged seven days or older with congenital hyperinsulinism (CHI). Based on an announcement released on 30 June, the application is based on clinical data from two Phase III studies and interim results from an ongoing long-term extension trial (NCT03941236). This includes results from a Phase III trial (NCT041724412), which tested dasiglucagon’s efficacy and safety in a hospital setting among 12 neonates and infants with CHI aged seven days to 12 months. In the first part of the trial, which took the form of a 48-hour crossover study, dasiglucagon reduced the need for glucose infusions by 55%. The application also features data from a second Phase III study (NCT03777176), which tested subcutaneous dasiglucagon infusions in 32 children with CHI aged three months to 12 years. ...
- Source: drugdu
- 116
- July 5, 2023
Former Alexion VP, 4 others find their ‘goose’ is cooked with SEC insider trading charges

The Securities and Exchange Commission (SEC) has revealed insider trading charges against five—including former Alexion Vice President Joseph Dupont and a Massachusetts police chief—who allegedly took advantage of prior knowledge of Alexion’s 2020 acquisition of Portola Pharmaceuticals. Dupont, 44, of Rehoboth, Massachusetts, was the head of go-to market transformation and business operations for Alexion until April of this year. He is alleged to have tipped off his childhood friend Shawn Cronin, the police chief of Dighton, Massachusetts, about the company’s intent to buy out Portola. Cronin, 43, is alleged to have passed the information to two other friends, one of whom told Paul Feldman, 48, of the deal. In all, four bought stock in Portola, which netted them more than $2.3 million, including $1.73 million to Feldman, the SEC said. One of the friends, Slava Kaplan, 45, who made $472,000 from his trades, texted Feldman in Russian: “Let’s hope our ...
- Source: drugdu
- 112
- July 5, 2023
Roche’s Evrysdi shows continued improvement in children with spinal muscular atrophy

Roche has announced positive new four-year results from an open-label extension study of its spinal muscular atrophy (SMA) treatment, Evrysdi (risdiplam), in young children. SMA is a severe and progressive neuromuscular disease affecting approximately one in every 10,000 babies. People living with the condition have insufficient levels of the SMN protein, which is essential to the function of nerves that control muscles and other functions such as swallowing, speaking, breathing and movement. Depending on the form of SMA, the patient’s physical strength and their ability to walk, eat or breathe can be considerably compromised or lost. Without treatment, children with type 1 SMA are not expected to live past age two and are never able to sit without support. Roche’s Evrysdi, which can be administered at home in liquid form by mouth or by feeding tube, is designed to treat the disease by increasing and sustaining the production of SMN ...
- Source: drugdu
- 115
- July 5, 2023
New technology to capture and release cfDNA on nanowire surfaces from urine

A group led by researchers at Nagoya University in Japan has developed a technology to capture and release cell-free DNA (cfDNA) on nanowire surfaces from urine. By extracting this DNA, they were able to successfully detect IDH1 mutation, a characteristic genetic mutation of gliomas, a type of brain tumor. Their findings increase the effectiveness of cancer detection tests using urine. They published their results in the journal Biosensors and Bioelectronics. Brain tumors are often examined only after the appearance of symptoms, such as paralysis of the limbs. But even when they are detected, they are often so advanced that it is difficult to remove them by surgery. Among these tumors, some of the deadliest are gliomas. These tumors have an average survival time as low as 12-18 months. Therefore, for the patient to have a chance of survival, early detection is necessary. As many patients have routine physicals in which ...
- Source: drugdu
- 127
- July 4, 2023
Study finds nighttime speed limits not effective in reducing e-scooter injuries

Motor vehicles are among the leading causes of death by injury, with the World Health Organization (WHO) reporting that road traffic accidents comprised over a fifth of all fatal injuries in 2015. Across the world, over 30,000 people suffer serious injuries from such accidents every day. Electric scooters (e-scooters) have been linked to an increased risk of harm. A new research paper published in the journal JAMA Network Open looks at the impact of nighttime speed limits on injury risk related to e-scooters. Introduction Since their introduction in many countries, e-scooters have been associated with high injury statistics, especially to the head and face. In particular, nighttime driving of e-scooters, or driving under the influence of alcohol or illegal substances, has been found to be associated with injury risk in a substantial proportion of cases. In attempts to reduce the toll from road traffic accidents, the safe system approach has ...
- Source: drugdu
- 125
- July 4, 2023
Australia authorizes MDMA, magic mushrooms for medical treatment

Australia on Saturday became one of the first countries in the world to allow the use of MDMA and magic mushrooms for medical treatment, in a bid to tackle certain mental health conditions. From July 1, authorized psychiatrists will be able to prescribe the drugs, also known as ecstasy and psilocybin, for the treatment of post-traumatic stress disorder and some types of depression. Authorities in Canada and the United States allow the medical use of one or both of the drugs, but only in clinical trials or with special permits. In February, Australia reclassified the drug entirely, after the country’s Therapeutic Goods Administration said trials had found the substances to be “relatively safe” when used in a “medically-controlled environment”. Supporters of the move hope the drugs can provide breakthroughs for mental health patients, when other treatments have failed. Mike Musker, a mental health and suicide prevention researcher at the University ...
- Source: drugdu
- 114
- July 4, 2023

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