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By PharmaCompass
2026-03-19
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As the war in the Middle East intensifies, the world is facing disruption of major air and sea routes. The war is already disrupting the flow of critical medicines to the Gulf. Drugmakers are choosing to wait and watch, as no major deal has been signed over the last week.
In news this week, the US Food and Drug Administration (FDA) approved Johnson & Johnson’s first-of-its-kind oral pill Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis. The agency also expanded the approval of GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy. It can now be administered to all adults.
Aldeyra’s eye drug reproxalap was rejected by the agency for a third time. The drug was being developed to treat dry eye disease (DED), a chronic condition characterized by insufficient tear production.
Meanwhile, German drugmaker Bayer is eyeing a label expansion for the use of its non-steroidal chronic kidney disease (CKD) drug, Kerendia (finerenone), to include non-diabetic patients. Kerendia is approved to treat CKD in patients with type 2 diabetes.
Roche expanded its artificial intelligence computing capacity by deploying 2,176 Nvidia Blackwell graphics processing units (GPUs) across sites in the US and Europe. This deployment will speed up work across its research and development operations.
In clinical trials, Ultragenyx’s gene therapy — DTX301 — significantly reduced levels of ammonia in patients’ bloodstreams. The therapy is used for the treatment of ornithine transcarbamylase (OTC) deficiency, a rare genetic disorder that prevents urea cycle function.
And a federal judge blocked key measures taken by the US Health Secretary Robert F Kennedy Jr (RFK Jr) to reshape America’s vaccine policy.
FDA approves J&J’s first-of-its-kind plaque psoriasis pill
FDA has approved Johnson & Johnson’s oral pill Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg. This first-of-its-kind drug offers a more convenient treatment option for patients with the chronic autoimmune condition that causes itchy, scaly, and inflamed patches of skin. J&J will be competing with other treatments for psoriasis in the market, such as Bristol Myers Squibb’s Sotyktu (deucravacitinib) and AbbVie’s Skyrizi (risankizumab).
Expands approval for GSK’s RSV vaccine: FDA has expanded the approval of GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, to include all adults. Arexvy was approved in 2023 as the first RSV vaccine for adults aged 60 and above, and for at-risk adults aged 50 to 59.
Aldeyra’s dry eye drug rejected again: FDA has handed Aldeyra’s reproxalap a third rejection. The drug was being developed to treat dry eye disease (DED), a chronic condition characterized by insufficient tear production.
Middle East war hits pharma industry as major supply routes get disrupted
The war in the Middle East is beginning to impact the pharmaceutical industry. It is disrupting the flow of critical medicines to the region, including cancer drugs and other treatments that require refrigeration. Major airports in the region have been closed or are operating below capacity due to strikes by Iran in response to US and Israeli attacks. While the conflict has not yet led to any major shortages, companies have started using alternative routes to avoid Middle Eastern airspace.
Lilly’s Ebglyss scores phase 3 win in children with atopic dermatitis
Eli Lilly’s atopic dermatitis (AD) drug Ebglyss (lebrikizumab-lbkz) achieved both primary and secondary endpoints in a phase 3 trial in children aged six months to 18 years. Ebglyss was approved by the FDA in September 2024 for children over 12 and adults with AD (also known as eczema) who weigh at least 40 kg. Lilly had acquired the drug through its US$ 1.1 billion acquisition of Dermira in 2020. In the trial, Ebglyss alleviated symptoms, while providing skin clearance and itch relief. Lilly now plans to seek a label update for Ebglyss.
Bayer eyes Kerendia label expansion: Bayer is eyeing a label expansion for the use of its non-steroidal chronic kidney disease (CKD) drug, Kerendia (finerenone), to include non-diabetic patients. Kerendia is already approved to treat CKD in patients with type 2 diabetes.
Ultragenyx’s gene therapy for rare disorder scores phase 3 win
American biopharma Ultragenyx's innovative gene therapy — DTX301 — scored a late-stage win by significantly reducing toxic levels of ammonia in patients’ bloodstreams. The therapy is used for the treatment of ornithine transcarbamylase (OTC) deficiency, a rare genetic disorder that prevents urea cycle function. This causes the build up of toxic ammonia in the blood, thereby affecting the brain. The therapy inserts a healthy copy of a gene into a patient’s cells.
Immutep’s Efti fails crucial phase 3 trial: Australian biotech Immutep has discontinued a crucial phase 3 trial for Efti (eftilagimod alfa) which is administered along with Keytruda (pembrolizumab) and was being developed as a first-line treatment for advanced non-small cell lung cancer (NSCLC). An interim analysis concluded the study was unlikely to meet its primary endpoints.
Federal judge blocks key measures in RFK Jr’s childhood vaccine policy
In the US, a federal judge blocked key measures taken by Health Secretary Robert F Kennedy Jr (RFK Jr) to reshape America’s vaccine policy, including steps such as reducing the number of shots routinely recommended for children, and revamping a federal advisory committee on inoculations. District Court Judge Brian Murphy ruled that Kennedy “disregarded” scientific methods for developing vaccine policies.
Roche deploys 2,176 Nvidia GPUs to speed up drug development
Roche has expanded its artificial intelligence computing capacity by deploying 2,176 Nvidia Blackwell graphics processing units (GPUs) across sites in the US and Europe. This deployment gives Roche the largest GPU footprint in the industry. Roche plans to build a hybrid-cloud AI factory designed to accelerate development of new therapeutics and diagnostics. These GPUs will help Roche compete with Eli Lilly, which announced a US$ 1 billion deal with Nvidia in January this year.
Genentech CEO pushes for affordable obesity drugs: Roche’s Genentech division is aiming to build a portfolio of obesity drugs that are more tolerable and affordable, its CEO Ashley Margaree has said. Roche had signed a deal with Denmark’s Zealand Pharma to acquire the rights to petrelintide, an experimental obesity treatment, for up to US$ 5.3 billion last year.
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