DRUGS
Lupin launches generic cancer drug in US
Lupin has launched a generic cancer treatment drug, Doxorubicin Hydrochloride Liposome Injection, in the US market. The product is a generic version of Baxter Healthcare Corporation's Doxil and is used to treat ovarian cancer, AIDS-related Kaposi's Sarcoma, and multiple myeloma. The drug had an estimated annual sales of USD 40.9 million.
Fairfax, Bain look to buy Gujarat API company Farmson
Canadian billionaire Prem Watsa's Fairfax Group and Bain Capital are in competition for a buyout of Farmson Basic Drugs, a leading API maker in India valued at ₹4,000 crore. Founded in 1969, Farmson is a major paracetamol manufacturer with a revenue of ₹1,750 crore in FY24. The company's concentrated focus on paracetamol production is a strength, but limited R&D poses challenges for diversification.
Aurobindo, Glenmark, FDC recall products in US market over manufacturing issues: USFDA
The New Jersey-based Aurobindo Pharma USA Inc initiated the Class 1 recall on July 11, it said. As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems. Similarly, a US-based subsidiary of Glenmark Pharmaceuticals is recalling 2,404 bottles of Indomethacin Extended-Release Capsules, produced at a Madhya Pradesh plant, due to "Failed Dissolution Specifications", USFDA said.
Alembic Pharma gets USFDA nod for generic drug
Alembic Pharmaceuticals has been granted final approval from the USFDA for its generic Betamethasone Valerate Foam, intended to treat moderate-to-severe psoriasis of the scalp. This medication is equivalent to Luxiq Foam by Norvium Bioscience. Alembic’s shares ended 0.97% lower at Rs 1,089.90 on the BSE.
USFDA pulls up Eugia for manufacturing lapses, data accuracy at Hyderabad plant
The US Food and Drug Administration (USFDA) has issued a warning letter to Eugia Pharma Specialities, a subsidiary of Aurobindo Pharma, citing significant manufacturing issues at its Telangana plant. The USFDA's inspection from January 22 to February 2, 2024, revealed problems including inaccurate production and process simulation data, falsified environmental monitoring records, and incomplete batch production and control records.
Govt bans 156 medicines including antibiotics, painkillers, multivitamins: Here is the full list
The Ministry of Health and Family Welfare has banned the manufacture, sale, and distribution of 156 fixed dose combinations. These include treatments for common ailments like colds and fevers. An Expert Committee and the Drugs Technical Advisory Board found no therapeutic justification for these combinations and identified potential health risks, leading to the prohibition.
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Govt bans 156 fixed-dose combo drugs over risks
FDCs are medicines that combine two or more drugs into a single dosage. The union health and family welfare ministry on Thursday issued a gazette notification, prohibiting manufacture, sale and distribution of these medicines based on the recommendation of an expert panel that evaluated 324 FDCs.
USFDA flags Telangana unit of Aurobindo Pharma arm
The letter, issued on August 15, was later made public by the USFDA, which stated that there was failure to ensure the accuracy of data in records for both production and process simulations, i.e. media fills. Media fill is a microbiological test to help prevent contamination during drug production.
Indoco Remedies gets USFDA nod to market Lofexidine tablets with 180 days exclusivity
Indoco Remedies Ltd was granted approval from the USFDA to sell its generic Lofexidine tablets, used for opioid withdrawal. This approval includes 180 days of market exclusivity. The company plans an immediate US launch, manufacturing the product in Goa. Expected sales are estimated at USD 15.59 million, with significant growth anticipated.
AstraZeneca gets $107 mln Pfizer verdict overturned in US cancer drug patent fight
On Wednesday, U.S. District Judge Matthew Kennelly invalidated Pfizer’s patents related to the cancer drug Nerlynx, overturning a jury's $107.5 million award against AstraZeneca. Pfizer had claimed AstraZeneca's Tagrisso infringed these patents. Judge Kennelly's ruling found the patents lacked sufficient written descriptions and were not reproducible by a skilled scientist. This decision dismisses the damages awarded in May and affects Pfizer’s ongoing patent infringement claims. The case, Wyeth LLC v. AstraZeneca Pharmaceuticals LP, was heard in the District of Delaware.
Alembic gets USFDA nod for generic medication
Alembic Pharmaceuticals announced approval from the USFDA to market Dabigatran Etexilate Capsules (110 mg) for deep vein thrombosis prophylaxis, equivalent to Pradaxa Capsules. The company now has 211 ANDA approvals. Shares closed 3.17% lower at Rs 1,076 on the BSE.
Dr Reddy's gets establishment inspection report from USFDA for Visakhapatnam units
Dr Reddy's Laboratories Ltd has obtained an Establishment Inspection Report from the USFDA for its Duvvada units, now classified as Voluntary Action Indicated. The units underwent an inspection from May 8 to May 17, 2024, which led to a Form 483 with observations. Dr Reddy’s planned to resolve the issues within the given time.
As monsoon takes hold, anti-infective, respiratory drugs' demand surges
Monsoon led to a surge in demand for respiratory, anti-infective, and anti-malarial products. The respiratory market saw a notable increase in Poractant Alfa usage. Anti-malaria medicines experienced significant growth, driven by seasonal patterns. Core therapeutic areas like cardiac, respiratory, and gastro contributed to the overall market growth.
India eases drug approval process, waives local trials for advanced therapies
In a major policy shift, the Indian government has waived local clinical trial requirements for drugs and vaccines approved by major international regulators (US, UK, Japan, Australia, Canada, EU). This move, aimed at expediting access to advanced therapies like CAR T-cell therapy and Sacituzumab govitecan, still ensures post-marketing surveillance by the CDSCO.
Domestic pharma market growth slips to 6% in July
Sheetal Sapale, VP, commercial, Pharmarack, said four key therapy segments - cardiac, anti-infectives, gastro and respiratory - have driven the growth of the market by showing "excellent" value growth. "Growth has slowed down in many therapies in July, but the core therapies have not degrown. The therapies with seasonal diseases are growing in double digits. They have pulled up the growth of the market as they have made significant contributions to IPM," she added.
India waives clinical trial requirement for drugs approved in developed markets
India has waived clinical trial requirements for new drugs with significant therapeutic advances that have been approved in the US, UK, Japan, Australia, Canada, or the EU. The Central Drugs Standard Control Organisation (CDSCO) stated that this move aims to speed up drug availability, especially for rare diseases, pandemics, and special defence needs.
Pharma industry urges govt for stable drug pricing policy
The Organisation of Pharmaceutical Producers of India (OPPI) has called for a stable and predictable drug pricing policy, urging the government to avoid using Para 19 of the Drug Pricing Control Order (DPCO), which allows significant price reductions in the public interest.
Sun Pharma's hair loss drug in the cross hairs in US
Leqselvi is used for the treatment of alopecia areata, an autoimmune disease that leads to hair loss, and was approved by the US Food and Drug Administration (USFDA) last week. Sun Pharma has been making preparations for months to launch the drug in July, but an injunction motion by the American drugmaker lncyte Corporation in the US District Court for the District of New Jersey has put the brakes on the launch.
Sanofi gets drug regulator nod to market RSV therapy in India
French drugmaker Sanofi announced on Thursday that it has received approval from India's Central Drugs Standard Control Organization (CDSCO) to market its novel therapy, Beyfortus, in India. The therapy is aimed at protecting newborns and infants from respiratory syncytial virus (RSV).
Govt plans crackdown on lookalike drug brands
According to people in the know, the government is likely to consider as valid only the brand names which were approved first by the regulator. Other same or similar sounding and lookalike brands will not be allowed to be marketed. Drug makers will soon be asked to upload formulation details along with the brand names of their products on the government's portal.
Drug MNCs for keeping patient aid plan out of trade margin formula
The Organisation of Pharmaceutical Producers of India (OPPI) recommended excluding Patient Assistance Programmes (PAPs) from Trade Margin Rationalisation to maintain affordability for patients. They noted that PAPs are crucial for providing access to expensive drugs, especially for oncology and rare diseases. OPPI also sought exemption for patented and orphan drugs from government-set price controls and opposed post-patent price cuts.
Sun Pharma gets US FDA nod for its specialty drug against baldness
Sun Pharma announced FDA approval of Leqselvi (deuruxolitinib) 8 mg tablets for severe alopecia areata, marking a major milestone after acquiring Concert Pharmaceuticals for $576 million. The drug, with a five-year marketing exclusivity, boosts Sun Pharma's specialty business. Shares rose 2.58%. Clinical trials showed significant hair regrowth in patients
Sun Pharma's drug to treat alopecia areata gets USFDA nod
Sun Pharmaceutical Industries Ltd announced that the USFDA has approved its drug LEQSELVI (deuruxolitinib) for treating adults with severe alopecia areata. The approval is based on Phase 3 clinical trials involving 1,220 patients. LEQSELVI provides a new treatment option for patients with significant hair loss due to this autoimmune disorder.
Budget 2024: Cancer patients get relief but senior citizens missed the attention
The Union Budget 2024, while significantly increasing health sector funding to ₹90,959 crore, failed to address the BJP’s poll promise of including senior citizens above 70 in Ayushman Bharat-PMJAY. The budget features customs duty exemptions for three cancer drugs and changes to basic customs duty for X-ray equipment. Reactions from healthcare leaders underscore the budget's focus on improving accessibility and infrastructure. However, the omission of the senior citizens' health cover highlights a key unfulfilled promise, leaving a gap in comprehensive healthcare improvements.
Budget 2024: Government proposes to fully exempt 3 cancer drugs from customs duty
The government proposes to cut custom duties on Trastuzumab Deruxtecan, Osimertinib and Durvalumab from 10 per cent to nil. Finance Minister Nirmala Sitharaman also proposed changes in the basic customs duty (BCD) on x-ray tubes and flat panel detectors for use in medical x-ray machines under the phased manufacturing programme, so as to synchronise them with domestic capacity addition.
Next leg of pharma sector growth necessitates skill advancement, innovation: Eco Survey
Economic Survey 2024: The domestic pharmaceutical industry in India needs skill advancement, innovation, and a robust supply chain to meet the expected segment size of USD 130 billion by 2030, according to the Economic Survey 2023-24 tabled in Parliament on Monday. Currently, the Indian pharmaceutical market is valued at around USD 50 billion, making it the world's third-largest by volume.
Pharma MNCs seek relief from price control for patented drugs
The Organisation of Pharmaceutical Producers of India (OPPI) is requesting exemptions for patented and orphan drugs from government price controls. They argue that current regulations hinder innovation and want more control over pricing post-patent expiry to provide economic incentives for inventors.
SC dismisses Sun Pharma's plea against NPPA's demand notice of Rs 4.65 cr for overcharging drug
The Supreme Court dismissed Sun Pharma's plea against a demand notice of Rs 4.65 crore by NPPA for overcharging for the drug Roscilox, upholding the Delhi High Court's decision. Sun Pharma challenged the demand for overcharged amount under DPCO, with the court finding no merit in the appeal. It noted Sun Pharma's direct purchase from the manufacturer and overlapping identities with Oscar Laboratories Pvt. Ltd.
USFDA approves Glenmark Pharma's seizure treatment drug
New Delhi-based Glenmark's USFDA-approved 15 mg and 25 mg Topiramate capsules, equivalent to Janssen's Topamax, will be marketed by Glenmark Pharmaceuticals Inc., USA. Topamax had recorded annual sales worth USD 21.9 million per IQVIATM (till May 2024). Glenmark's US portfolio has 198 products, 50 ANDAs pending, and seeks growth through external development partnerships.
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