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Neurotech Pharmaceuticals’ one-time gene therapy comes in a surgical implant, and it’s now the first FDA-approved treatment for a rare vision-loss disorder.

The approval covers the treatment of macular telangectasia type 2 (MacTel) in adults. The Neurotech therapy, known in development as revakinagene taroretcel, will be marketed under the brand name Encelto. (MedCity News)

The FDA approved an expanded indication of Soliris, an IV-administered monoclonal antibody for patients aged 6 years and older with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive.

According to a release from the Muscular Dystrophy Association, Soliris (eculizumab, Alexion/AstraZeneca) is the first and only treatment available to address the neuromuscular disease in this younger patient population.

Administered by infusion, Soliris is solely available through a restricted Risk Evaluation Management Strategy (REMS) program. The REMS requires patients to be vaccinated against meningococcal disease at least 2 weeks ahead of treatment initiation. (Healio)

The FDA announced the approval of Celltrion USA’s Omlyclo as the first biosimilar to reference Xolair. The biosimilar was also approved with interchangeability status and is the first respiratory biosimilar in the US.

Omlyclo is designed to help people manage a range of allergic and inflammatory conditions. It is approved for moderate to severe asthma in adults and children 6 and older who have allergies and aren’t getting enough relief from inhaled steroids. It also helps adults with chronic sinus inflammation and nasal polyps who haven’t had success with nasal corticosteroids. (Center for Biosimilars)

The FDA approved an expanded indication for scPharmaceuticals’ furosemide injection to include treating edema in adult patients with chronic kidney disease (CKD), including nephrotic syndrome.

The expanded treatment is expected to be available by next month. (Pharmacy Times)

Roche is paying $1.65 billion in confirmed upfront fees to add to its burgeoning obesity pipeline. The outlay, plus up to $3.6 billion in milestones, has secured Roche the right to co-develop and co-commercialize Zealand Pharma’s long-acting amylin analog petrelintide.

Excitement about the potential of amylin assets intensified after Zealand and its rivals shared data at the EASD 2024 meeting in September.

The excitement has blossomed into deals in recent days. AbbVie paid $350 million upfront for Gubra’s phase 1 prospect last week. Roche went bigger still Wednesday with its deal for one of the leading assets in the space. (Fierce Biotech)

Johnson & Johnson and Protagonist Therapeutics have bet their oral IL-23 drug will be an immunology blockbuster, and they are now one step closer to that goal.

The companies said Monday that the drug, known as icotrokinra succeeded in a phase 2b trial for ulcerative colitis. It’s the program’s first win in an IBD trial, and it could potentially open up additional markets beyond the dermatology conditions that have been the focal point of icotrokinra’s R&D thus far.

They project more than $5 billion in peak annual sales if icotrokinra sees continued clinical trial success. (Endpoints)

Merck & Co. opened a new vaccine manufacturing plant in Durham, North Carolina, that will boost the company’s domestic production at a time when the Trump administration has roiled trade relations with tariffs on foreign imports.

The $1 billion facility is the product of a broader investment campaign by Merck to increase US manufacturing and R&D. The pharmaceutical firm, which has spent more than $12 billion on US capital investment since 2018, plans to invest another $8 billion in the country by 2028.

Merck sells a number of vaccines, including Gardasil, which protects against human papillomavirus, as well as shots for pneumococcal disease, rotavirus, measles, mumps and rubella. (Biopharma Dive)

The Trump administration is withdrawing the nomination of Dave Weldon as its pick to run the Centers for Disease Control and Prevention, according to two sources familiar with the decision.

The former Florida lawmaker was set to appear before the Senate health committee this morning.

The sources said the administration had concerns about Weldon’s longtime vaccine criticism.

Weldon has promoted anti-vaccine theories for decades, according to a STAT review of his congressional record. He held fast to the belief that vaccines caused autism, even though science has since debunked that theory.

In 2007, he introduced a bill to ban thimerosal from vaccines based on a perceived link to autism. Thimerosal was removed from all childhood vaccines in the U.S. in 2001. (STAT)

The so-called Department of Government Efficiency (DOGE) won’t cancel the lease on a FDA drug testing laboratory in St. Louis, according to sources.

While there is no indication for the course reversal, several former FDA officials have highlighted its important role in ensuring the safety and efficacy of drugs that come to market.

Last week, DOGE posted on its website that it was canceling leases for 30 FDA field offices, including a 52,000 sq ft drug testing facility described by former agency officials as the most important FDA drug testing lab.

However, within a few days of making the announcement, it seems the department has reversed its decision to end the lease that it claimed was worth $2,457,367 annually and would save an estimated $19,249,372. (RAPS)

For five weeks, employees at NIH technology transfer offices have been barred from filing new patent applications and been restricted from licensing existing ones, according to emails obtained and interviews with current and former NIH employees.

The NIH’s various technology transfer offices protect the intellectual property of discoveries made at NIH and at the CDC and license those inventions to pharmaceutical, medical device, and biotechnology companies for further development into commercial products.

The longer the disruptions go on, the more potential there is for the public to lose out on taxpayer-funded biomedical discoveries and for America to give up its edge on the international stage, experts say. (STAT)

When this mucosal barrier is damaged, toxins and other harmful material leak into the underlying tissue, causing a variety of health problems. The weakening of this barrier is attributed to a wide range of inflammatory bowel diseases, leading to increased permeability of the walls.

First, these methods are invasive, don’t offer a complete visual analysis, and require a visit to a hospital.

Moreover, they don’t offer a real-time view of gut health and the accompanying risks to physicians.

The team has created what they call an ingestible bioimpedance sensing capsule for monitoring the internal gut health. It could very well push us beyond wearable health sensing.

The capsule comes embedded with a flexible, four-probe sensor coated with a conductive polymer layer. The device measures change in the impedance levels within and sends the information in real-time through Bluetooth connectivity.