| |AUGUST 20269EARLY FDA APPROVAL GIVES GSK A BIG LUNG CANCER BREAKTHROUGHFDA SPEEDS UP REVIEW OF PFIZER'S PROSTATE CANCER TREATMENTNOVARTIS RIDES BLOCKBUSTER DRUG WAVE TO STRONG Q2 SALESCONGO EBOLA CRISIS NEARS 1,000 DEATHS AS CASES HIT 2,473DR REDDY'S API FIX PAVES WAY FOR GENERIC SEMAGLUTIDEGSK has received Early FDA Approval for its new lung cancer drug, Jideytro. The decision marks a major milestone for the company as it enters the competitive market for targeted lung cancer therapies. The Early FDA Approval marks a major step for GSK in the fast-growing lung cancer market. The company received approval for Jideytro to treat adults with ROS1-positive NSCLC who have already received prior treatment. The decision came weeks before the agency's expected review date. The approval strengthens GSK's oncology business. It also gives the company a new product to compete in a market with several established treatments. POThe Prostate Cancer Treatment from Pfizer has taken a major step toward expanded use in the US. The company has received FDA Priority Review for its supplemental New Drug Novartis posted stronger Q2 sales, helped by robust demand for its blockbuster medicines. The Swiss drugmaker also maintained its full-year 2026 outlook. The company delivered higher revenue despite lower profit and free cash flow. Strong performance from Kisqali, Kesimpta, Pluvicto, Leqvio, and Scemblix supported overall growth.The company also reported fresh regulatory approvals and important pipeline milestones. The company reported second-quarter net sales of USD 14.4 billion. Sales increased 3% in US dollars and 1% at constant currencies. Growth came mainly from oncology and specialty medicines. However, profitability remained under pressure. Operating income declined 3% at constant currencies. POThe Congo Ebola Crisis has entered another critical phase. The outbreak has now recorded 2,473 confirmed cases and 999 deaths. The latest figures mark a sharp rise from previous updates. They also highlight the growing challenge of Dr Reddy's API fix has cleared the way for the return of generic semaglutide supplies by November. The company expects production to resume after resolving a quality issue linked to the active pharmaceutical ingredient. The restart is expected to strengthen its presence in the growing diabetes and obesity treatment market. The company is also targeting production of 6-7 million pens during the second half of FY27.The temporary disruption had delayed commercial supplies in India and Canada. Company executives said the manufacturing issue has now been addressed. Fresh batches are expected to reach the market from November. The product remains one of Dr Reddy's key growth drivers after the patent expiry of the original medicine in India. POcontaining the Ebola outbreak in the Democratic Republic of the Congo.Health authorities reported 50 new cases on Monday. Most recent infections were recorded in the eastern provinces of North Kivu and Ituri. These regions remain the worst-hit areas since the outbreak began. Officials continue to investigate suspected infections and deaths as surveillance teams expand their response. POApplication. The application seeks approval for Talzenna in combination with Xtandi.The treatment is intended for adults with Metastatic Castration-Sensitive Prostate Cancer who have HRR Gene Mutations. FDA is expected to make its decision in the fourth quarter of 2026.The Priority Review follows positive results from the TALAPRO-3 study. The trial showed the drug combination significantly reduced the risk of disease progression or death. If approved, the expanded label could give eligible patients another targeted treatment option earlier in their disease journey. PO
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