Pharma

• Cue Biopharma announced positive results from a Phase 2 clinical trial of its CUE-221 treatment for chronic spontaneous urticaria, a condition causing chronic hives. • The trial results demonstrated that the drug achieved significant efficacy and maintained a favorable safety profile for patients. • These findings suggest a potential new therapeutic option for patients suffering from chronic hives who may not respond to existing treatments.

• Connect Biopharma reported that its asthma trial reduced failures by 66% based on recent patient data. • Lung function improved by 250 mL by Day 7 compared to 120 mL for the placebo group among 160 patients. • These results impact the drug's regulatory approval and market potential because investors use FEV1, a measure of how much air a person can exhale, to judge if respiratory treatments work.

• The White House signed secretive agreements with 26 drugmakers that may exempt various medicines from mandatory price reductions in Medicare. • A new analysis indicates these deals could drastically reduce the projected savings from the "most-favored nation" pricing policy, which aims to align U.S. drug costs with lower prices paid abroad. • These exemptions could limit the government's ability to lower prescription costs for millions of Medicare beneficiaries.

• Helus Pharma will participate in the Morgan Stanley Healthcare Conference, where Michael Halstead will give a fireside chat on September 16. • The chat will be webcast live at 8:30 a.m. EDT and a replay will be available on Helus Pharma's investor relations website. • The company's products, including HLP003 and HLP004, have not been evaluated by regulatory authorities such as the US Food and Drug Administration, and their efficacy has not been confirmed by approved research.

• The CEO of Helus Pharma will participate in a live webcast on September 14 during the H.C. Wainwright conference in New York. • The presentation begins at 9 a.m. EDT and will be available for replay on the company's Events & Presentations page. • Investors and partners can gain direct insight into the company's current status and its various programs, including HLP003 and HLP004.

• The Sensex dropped 383 points and the Nifty fell below 23,800 during the most recent trading session. • Pharma stocks rose 0.75%, while other sectors including Information Technology, Media, Metal, PSU Bank, and Realty fell between 1% and 2.8%. • Investors may treat price rebounds as opportunities to sell rather than a recovery until the Nifty reclaims the 23,900–24,000 zone.

• Helus Pharma CEO Michael Halstead is scheduled to participate in a fireside chat during a conference on September 11. • The event will be webcast at 8 a.m. EDT, with a recording later made available on the company's investor relations website. • The presentation comes amid ongoing development of the company's NSA programs, including HLP003 and HLP004.

• 60 Degrees Pharmaceuticals will release a public presentation on September 11 regarding its medicines for vector-borne diseases. • Following the presentation, company management will meet with institutional investors in New York from September 14-16. • The company currently commercializes ARAKODA (tafenoquine) for malaria prevention in the U.S. and Australia and is conducting three active clinical trials for babesiosis.

• The FDA approved updated 2026-2027 COVID-19 vaccines targeting the XFG variant on August 27, with doses shipping immediately to pharmacies, hospitals, and clinics. • While the vaccines are now physically available across the country, federal eligibility guidance remains unsettled, leaving uncertainty regarding who qualifies for the shots. • This rollout is critical for maintaining immunity against evolving strains, though clarity on insurance coverage and specific recipient criteria is still missing.

Foundayo will be available on private prescription, with pharmacists warning of counterfeit GLP-1 problemA new daily pill that treats diabetes and helps with weight loss will be available in UK pharmacies from Monday.Pharmacists said the move would be welcome for people who cannot use weight-loss jabs, but also issued a warning over the growing problem of fake, unlicensed or counterfeit versions of GLP-1 tablets. Continue reading...

• Jubilant Pharmova Ltd announced that the USFDA has approved commercial batch manufacturing for the first product on Line 3, a new Isolator-based fill-and-finish line. • The approval applies to the Jubilant HollisterStier LLC (JHS) contract manufacturing facility located in Spokane, Washington, US. • This development is significant as it expands the production capabilities of Jubilant's subsidiary network, including Jubilant Pharma Holding Inc. and Jubilant Pharma Limited, Singapore.

• Helus Pharma has appointed Michael Halstead, the former President of Intra-Cellular Therapies, as its new Chief Executive Officer. • The company successfully completed patient enrollment for its Phase 3 APPROACH study evaluating the drug candidate HLP003. • To support late-stage development and future commercialization, Helus Pharma has secured $50 million in new funding.

• Researchers are testing a novel approach to treating depression by using anti-inflammatory drugs to calm the immune system rather than targeting brain chemicals. • Early results from a small clinical trial indicate that this immune-focused strategy shows promise in alleviating depressive symptoms. • Parallel developments in pharmacology include the emergence of a new drug designed to halt the progression of deadly fatty liver disease.

• The Medicines and Healthcare products Regulatory Agency (MHRA) is proposing a shake-up of the UK's medicines approval process to accelerate the development of treatments for rare diseases. • With approximately 10,000 rare diseases existing, the vast majority currently lack effective therapies, creating significant gaps in patient care. • The economic impact is severe, with the MHRA estimating that delayed diagnoses cost £340 million annually and health-related disability costs reach £4.7 billion.

• Helus Pharma reported its financial results for the first quarter of fiscal 2027, ending June 30, 2026, alongside key business updates. • The company appointed former Intra-Cellular Therapies President Michael Halstead as CEO to oversee late-stage development and future commercialization efforts. • Enrollment has been completed for the Phase 3 APPROACH pivotal study evaluating HLP003 for the treatment of Major Depressive Disorder (MDD).

• Helus Pharma has released its financial results for the first quarter of fiscal 2027 and shared recent business updates. • The company appointed Michael Halstead, the former President of Intra-Cellular Therapies, as its new Chief Executive Officer. • Halstead is tasked with guiding the company through the critical phases of late-stage development and eventual commercialization.

• The Indian stock market closed lower, with the Sensex slipping 380 points and the Nifty ending at 24,470. • Sectoral performance was mixed; Nifty Pharma rose 1% and IT gained 0.40%, while Realty, FMCG, and Metal indices each declined by 1%. • Investor behavior shows increased risk awareness, with debt fund collections shifting heavily toward liquid and short-term instruments and arbitrage funds.

• Medexus Pharmaceuticals Inc. experienced a significant stock price surge of 8.06% amid a spike in trading activity and increased market attention. • The company operates as a specialty pharmaceutical firm focusing on the commercialization and marketing of branded products for rare diseases and oncology support in Canada and the U.S. • Analysts advise investors to review recent regulatory filings and news releases to determine if the rally is driven by specific operational or financial changes.

• Leading brokerages have issued updated stock calls, upgrades, and target price revisions for several companies ahead of today's trading session. • Key companies on the radar include Bharat Forge, Gland Pharma, Zydus Life, Info Edge, Fractal Analytics, PNB, Afcons Infra, Vodafone, and Entero Health. • Analysts highlight growth drivers such as domestic business strength and generics exports, with specific projections including a 13% CAGR in loans and a 0.9% ROA by FY27 for certain entities.

Industry body calls for more regular reviews of repeat prescriptions to tackle ‘growing problem’The amount of wasted medicines thrown away in England in one year could fill 75 swimming pools, according to a pharmacy group.The National Pharmacy Association (NPA) estimated that 3,400 tonnes of partly used medicines were disposed of in England in 2024-25. Continue reading...

• An FDA advisory panel has recommended the use of an experimental Replimune treatment for advanced melanoma, despite the agency having rejected the drug twice previously. • Rising oil prices driven by the conflict with Iran have sparked industry concerns regarding the vulnerability of essential medicine supply chains to price volatility. • These developments highlight critical regulatory shifts for oncology treatments and the impact of geopolitical instability on pharmaceutical costs.

• Investors are monitoring several stocks today, including Meesho, Poonawalla Fincorp, and Sudeep Pharma, as the market recovers from a Tuesday decline. • Meesho is in focus after 27 investors, including Goldman Sachs, Fidelity, and Morgan Stanley, purchased shares previously held by Elevation Capital and Peak XV Partners. • Other notable buyers in the Meesho deal include Axis Mutual Fund, HSBC Mutual Fund, and the Abu Dhabi Investment Authority (ADIA).

• Helus Pharma has appointed a new CEO to lead the company as it advances its lead candidate, HLP003, toward potential commercialization. • The company announced that enrollment is now complete for the APPROACH clinical trial, with topline data expected to be released in Q4 2026. • Enrollment remains ongoing for the EMBRACE trial, as the company works to confirm the effectiveness and safety of the treatment in large patient groups.

• On 28 April 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority introduced the most significant package of clinical trial reforms in over 20 years. • The legislative changes aim to accelerate the setup of low-risk trials and streamline the process for making modifications to existing studies. • These reforms matter because they are designed to provide patients with earlier access to innovative medicines by reducing regulatory bottlenecks.

• Several stocks, including Maruti Suzuki, Bandhan Bank, Indian Hotels, and Aurobindo Pharma, are expected to be in focus on Wednesday, July 22. • A key highlight is the announcement of a $98.44 million acquisition of a 30 per cent stake in HL Klemove India from South Korea's HL Klemove Corporation. • These developments are significant as they may influence investor sentiment and stock price volatility for the mentioned companies.

• Helus Pharma has completed enrollment ahead of schedule for the Phase 3 APPROACH study, which evaluates HLP003 as an adjunctive treatment for Major Depressive Disorder. • The company is continuing enrollment for EMBRACE, a second pivotal study within the Phase 3 PARADIGM Program, while rolling participants into the EXTEND study for long-term safety data. • This milestone is significant as HLP003 has previously been granted Breakthrough Therapy designation, signaling its potential to provide substantial improvement over existing therapies.

• The Pharmaceutical Journal reported on several key healthcare developments, including progress toward a single national formulary and the potential introduction of a pharmacy performers list. • The publication highlighted a "stark lack of government response" regarding the valproate redress scheme, signaling ongoing frustration over compensation for affected individuals. • Efforts are underway to establish closer regulatory ties between the UK, India, and the United States to streamline pharmaceutical oversight.

• The FDA has issued reminders to over 2,200 medical product companies and researchers to comply with clinical trial results submission requirements. • Data shows that 29.6% of required trial results are currently missing from ClinicalTrials.gov, with negative outcomes frequently going unreported. • This lack of transparency creates a publication bias that distorts the reality of drug development by overrepresenting successes and hiding failures.