Tag: USFDA

Wockhardt to use QIP funds to pare debt

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Habil F Khorakiwala, Chairman, Wockhardt says the company will use the proceeds of the recent qualified institutional placement (QIP) to pare debt of ₹100-110 crore and to conduct phase three clinical trials for a new antibiotic, WCK 5222.

Funds managed by veteran investors Madhusudan Kela and Prashant Jain are among the institutions that invested in the QIP. The drugmaker approved the closure of the institutional share sale on March 26, raising ₹480 crore.

As part of the placement, Wockhardt issued 92.85 lakh equity shares at an issue price of ₹517 per share, representing a 5% discount to the QIP floor price of ₹544.02 per share.

Khorakiwala said the clinical trial for WCK 5222 is expected to be completed by next year. The company will file for approval in other markets. “We expect the approval to come sometime in early 2026,” he said.

The global pharmaceutical and biotechnology company reported a 7% growth in net sales to ₹2,124 crore in April-December 2023.

The earnings before interest, taxes, depreciation and amortisation showed a staggering 80% year-on-year (YoY) growth to ₹173 crore in the period under review.

Wockhardt’s growth trajectory in the last three years has been led by vaccines and novel drug discovery of WCK 5222, Nafithromycin, and Emrok. Demands for diabetes biosimilars for India and emerging markets also contributed to the company’s consolidated position in the market.

A total of six programmes of Wockhardt have received Qualified Infectious Disease Product (QIDP) status from the United States Food and Drug Administration (USFDA). These are eligible for a fast-track development process and priority review.

The current market capitalisation of the company is ₹8,951.33 crore.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

US lawmaker questions FDA for no inspection of Musk’s Neuralink

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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A US lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon Musk’s Neuralink before allowing the brain implant company to test its device in humans.

Reuters reported last month that FDA inspectors found problems with record keeping and quality controls for animal experiments at Neuralink last June, less than a month after the startup said it was cleared to test its brain implants in humans.

Neuralink, which first tested its device in monkeys and other animals, is now testing the device in humans. The company makes a brain-chip which enables paralyzed patients to control a computer using only their thoughts.

In a letter to the FDA on Monday, Democratic US Representative Earl Blumenauer said he was concerned the agency ignored “troubling evidence” of animal testing violations that had been raised dating back to at least 2019.

Blumenauer also cited reports by Reuters since late 2022 that described employees’ complaints of “hack jobs” of animal experiments due to a rushed schedule, causing needless suffering and deaths. Employees also worried that data quality would be compromised, the media organization reported at the time. He asked the FDA to explain how it reconciled reports of such lapses with its decision to authorize Neuralink’s human trial.

“These alleged failures to follow standard operating procedures potentially endangered animal welfare and compromised data collection for human trials,” wrote Blumenauer, who serves on the House Ways and Means subcommittee on health.

In response to queries from Reuters about the letter, the FDA said it would respond to the lawmaker directly. The agency also said it routinely carries out inspections after a human trial is approved. When it inspected Neuralink, the FDA said it did not find violations that would undermine the safety of the trial.

Neuralink did not immediately respond to questions.

In recent years, a handful of device companies have begun testing such brain implants in humans, including Synchron and Blackrock Neurotech, who have both demonstrated the ability of patients to control certain actions with their thoughts.

Last week, Neuralink presented a livestream on Musk’s social media platform X, showing how the first patient implanted with its brain device was able to play online chess using his mind. Noland Arbaugh, a 29-year-old who was paralyzed below the shoulders after a diving accident, also posted a comment on X by relaying his thoughts.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Neuland Laboratories Hyderabad unit gets USFDA clearance

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Shares of Neuland Laboratories are trading with gains of 6% on Friday, extending its weekly gains to over 8%.

The company informed the exchanges that the USFDA inspection of its Bonathapally unit in Hyderabad was completed successfully with no observations issued under form 483. Neuland made this announcement in an exchange filing

Neuland’s Hynderbad unit was inspected by the US drug regulator from March 18 to March 22 this year.

The company’s Bonathapally unit is an API manufacturing unit with an overall capacity of 233 KL. The facility also boasts of an hydrogenation reaction volume of 7.4 KL and a solvent recovery system of 100 KL per day.

Based on the December quarter shareholding pattern, domestic Mutual Funds own a 1.83% stake in the company, while Alternate Investment Funds have a 4.19% stake. Among these, Malabar Value Fund has a 1.63% stake.

Malabar India Fund has a 9.95% stake as well.

Among prominent public shareholders include Kedia Securities, with a 1.25% stake and Mukul Agrawal, who has a 3.12% stake.

Shares of Neuland Laboratories are trading 6% higher at ₹6,392. The stock has gained nearly 300% over the last 12 months.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Biocon Biologics CEO terms Eris Lifesciences deal as enabling, not restricting

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Biocon Biologics’ collaboration with Eris Lifesciences is not a restrictive arrangement but an enabling one, said Shreehas Tambe, MD and CEO of Biocon Biologics in an interview with CNBC-TV18.

“It does not prevent us from working with others but certainly these particular brands – Basalog and Insugen – that we have commercialised, would be exclusive to Eris Lifesciences,” he said.

Basalog and Insugen are insulin products used in the treatment of diabetes.

Biocon Biologics, the biosimilars company and a subsidiary of Biocon., sold its Indian formulation business to Eris Lifesciences for ₹1,242 crore.

Biocon Biologics also entered into a long-term commercial collaboration with Eris Lifesciences to expand patient access to its portfolio of metabolics, oncology and critical care products in India.

Tambe sees this as a complementary collaboration between two existing partners building on a relationship that allows to deliver on that ambition of reaching one in five insulin-dependent diabetics in the country.

Biocon Biologics will continue to manufacture and supply its high-quality biologics to patients in India. “We are not looking to exit anything, we are very committed to India and patients here and we will be looking to strengthen our presence along with Eris Lifesciences – a chronic therapy-focused drug firm – who will represent far stronger commercial reach than we had,” he mentioned.

The transaction value of ₹1,242 crore translates to an accretive multiple of 3.4 times of revenue and 18 times of earnings before interest, taxes, depreciation, and amortisation (EBITDA).

Also Read | Biocon Biologics gets Canada market entry date for ophthalmic drug Yesafili

The US Food and Drug Administration (USFDA) has classified Biocon Biologics’ Malaysian plant as Official Action Indicated (OAI).

Tambe said the company is working with the USFDA to see how it can resolve it.

For more, watch the accompanying video

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Zydus Lifesciences gains 3% on USFDA nod for injections to treat neuro disorders

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Zydus Lifesciences Ltd shares gained more than 3% on Thursday after the company announced receiving approval for two injections from the United States Food and Drug Administration (USFDA).

In two separate filings to the stock exchanges, the pharma company said that it has received tentative approval from the US drug regulator for Edaravone Injection, along with final approval for Chlorpromazine Hydrochloride Injection.

The pharmaceutical company said in a press release that the USFDA has given its tentative approval to Zydus Lifesciences, along with its subsidiaries and affiliates, for the manufacture and marketing of Edaravone Injection in the dose 30 mg/100 mL (0.3 mg/mL), a single-dose vial.

The Edaravone injection is used in the treatment of a certain type of nerve disease termed ‘amyotrophic lateral sclerosis’ (ALS), which is commonly called Lou Gehrig’s disease. It’s a fatal motor neuron condition that leads to degeneration of nerve cells in the spinal cord and brain.

Zydus Lifesciences has also received the USFDA final approval for the manufacture and market of Chlorpromazine Hydrochloride Injection USP, 25 mg/mL and 50 mg/2 mL (25 mg/mL), single-dose vials.

This injection is used for treating certain mental or mood disorders, such as schizophrenia, psychotic disorders, manic phase of bipolar disorder, severe behavioural problems in children.

It is also indicated to control nausea, relieve prolonged hiccups, relieve restlessness or anxiety before surgery, while also in the treatment of a certain liver problem called porphyria, along with treating tetanus.

Both injections will be produced at Zydus Lifesciences Group’s injectable manufacturing facility located at Jarod, near Vadodara in Gujarat.

As of December 31, 2023, Zydus Lifesciences Group received a total of 390 approvals and has filed more than 460 abbreviated new drug applications (ANDAs) since the process of filing started back in FY 2003–04.

Shares of Zydus Lifesciences were trading 2.88% higher at ₹996.55 apiece on BSE at 1:20 pm.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Aurobindo Pharma get US FDA approval for Fingolimod Capsules, 0.5 mg

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Aurobindo Pharma Limited on Friday, March 1 announced that it has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Fingolimod Capsules, 0.5 mg. These capsules will be launched in the US market in March 2024.

Fingolimod Capsules, 0.5 mg are prescribed to patients with relapsing forms of multiple sclerosis (MS). The capsules reduce the frequency of clinical exacerbations and delay the accumulation of physical disability in such patients.

The medicine manufactured by Aurobindo Pharma is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation.

The approved product has an estimated market size of $447.3 million for the twelve months ending January 2024, according to IQVIA. Aurobindo claims to have a total of 505 abbreviated new drug application (ANDA) approvals including 486 final approvals and 19 tentative approvals from US FDA.

The Hyderabad-headquartered company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Shilpa Medicare gains nearly 4% after USFDA completes inspection at Hyderabad lab with zero observation

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Shares of Shilpa Medicare gained nearly 4% on Friday after the company announced that the United States Food and Drug Administration concluded its inspection at the company’s Bio Analytical Laboratory in Hyderabad with zero observations.

The US drug regulator conducted an inspection at Bio Analytical Laboratory, Unit 7, in the Nacharam area of Hyderabad, from February 26 to March 1, Shilpa Medicare said in a filing to the stock exchanges on Friday.

The inspection has now been concluded and closed by the US health regulator without any 483 observations, the company said.

This implies that Shilpa Medicare’s said laboratory in Hyderabad showed satisfactory compliance towards the facility, systems, and acceptability of the data generated from the said laboratory.

This newly set-up Centre for bio-analytical testing received European Regulatory Authority clearance recently.

“This Unit of Shilpa Medicare is engaged in testing of biological samples that supports all exploratory pharmacokinetic studies, bioavailability studies and bioequivalence studies, while complying with good clinical practices and good laboratory practices as per the global regulatory standard,” the pharmaceutical company said in an exchange filing on March 1, 2024.

The pharma company’s shares gained as much as 3.72% to a high of ₹432 apiece on BSE. The stock gained over 12% in the last one month and nearly 20% over the last three months. So far in the year, Shilpa Medicare’s shares have jumped 30%, while increasing significantly by 62% in the past one year.

Shilpa Medicare Ltd shares closed at ₹418.35 apiece, up 0.3%, on BSE.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

US FDA official emphasises the need for strong quality culture amidst growing data integrity issues in pharma

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Sarah McMullen, the Country Director at the US Food and Drug Administration (FDA), recently shared insights into the growing concerns about data integrity issues within pharmaceutical facilities. While acknowledging the increased identification of such issues, she emphasised the need for a strong quality culture and proactive measures to address these challenges.

McMullen highlighted that data integrity issues are not isolated incidents but are found throughout manufacturing and laboratory facilities. She emphasised the importance of fostering a robust quality culture within organisations.

“What we want to see from companies is not just a quality motto, which most companies should have and do have; we want to see them empower their employees at every level to make the right decisions regarding product quality and to have the accountability to follow that up. And so that’s maybe one of the pieces that we think could solve some of these data integrity issues,” McMullen said in an interview with CNBC-TV18.

Discussing the broader compliance landscape, McMullen noted an overall improvement in compliance within the pharmaceutical industry in India. Post-COVID, the FDA conducted a significant number of follow-up compliance inspections, followed by an increased focus on surveillance inspections. The number of surveillance inspections conducted in the past year more than doubled compared to the previous year, contributing to enhanced compliance rates, she added.

While it remains challenging to ascertain whether data integrity issues existed before but went unnoticed, McMullen acknowledged the current efforts to discover and address them. The FDA aims to take concerted actions to rectify these issues and ensure the integrity of data across pharmaceutical facilities.

McMullen emphasised that data integrity is not limited to specific locations and urged the entire pharmaceutical industry to engage in improving practices. Recognising the global nature of the issue, she called for collaborative efforts to enhance data integrity standards and practices worldwide.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Orchid Pharma shares gain after UTI-treatment drug gets USFDA approval post EU nod

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Shares of Orchid Pharma have cooled off from the day’s high, having gained as much as 11% on Monday, after the company received approval from the United States Food and Drug Administration (USFDA) for a drug used in treating complicated urinary tract infections (UTI) in adults.

The new drug is expected to be launched in the US, the largest pharmaceutical market in the world, within the next couple of quarters. It will be marketed under the brand name Exblifep, with estimated global commercial peak sales projected to reach $150 million – $200 million, Orchid Pharma said in a filing to the stock exchanges.

The approved drug, Enmetazobactam, in combination with cefepime, is indicated for use in adults with complicated urinary tract infections (cUTI) including pyelonephritis, Orchid Pharma informed the bourses.

Enmetazobactam was originally discovered and developed by Orchid Pharma and subsequently licensed to Allecra Therapeutics.

Allecra acquired the global (excluding India) development and commercialisation rights from Orchid.

The USFDA approval follows a positive recommendation for the drug’s use in the European Union (EU) from the EU Committee for Medicinal Products for Human Use (CHMP).

Orchid Pharma will receive royalties in the range of 6% – 8% on the sales of Exblifep, translating to peak annual royalties of approximately $12-16 million.

Additionally, the company retains commercialisation rights for Enmetazobactam in India, where it is expected to achieve sales of around ₹ 200 crore, as estimated by Systematix.

Overall, Orchid Pharma’s discovery and successful approval of Enmetazobactam represent a significant achievement in the pharmaceutical industry, with promising prospects for both global and domestic markets.

Nuvama estimated potential sales of $40 million in financial year 2025 and $80 million in financial year 2026 of the said drug. The royalty income is anticipated to contribute between 2% – 5% to Orchid Pharma’s current core business revenue according to the brokerage which would translate to around $2 million in financial year 2025 and $5 million in financial year 2026.

Shares of Orchid Pharma are trading 2.5% higher currently at ₹1,247. The stock has risen 220% over the last 12 months.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Aurobindo Pharma shares jump over 3% as USFDA completes inspection at Telangana unit with zero observations

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Aurobindo Pharma shares jumped more than 3.5% on Friday, February 16, after the pharma company said the United States Food and Drug Administration (USFDA) completed the inspection at the manufacturing unit of its synthetic peptides active pharmaceutical pngredient (API) business arm, Auro Peptides Ltd in Telangana.

The USFDA’s inspection had zero observations, Aurobindo Pharma said in a stock exchange filing.

Aurobindo Pharma said the US regulator conducted an audit at the Auro Peptides’ manufacturing unit from February 12 to February 16, 2024.

The manufacturing unit of the company is located at the Indrakaran Village of Kandi Mandal in the Sangareddy District of Telangana.

The pharmaceutical company has come under regulatory scrutiny recently as its formulation manufacturing facility, Eugia Unit III, is likely to be facing compliance issues.

The US health regulator issued nine observations in an inspection conducted at the Eugia Unit III plant from January 22 to February 2, 2024.

As per industry experts, these observations pointed out by the USFDA indicate problems with paperwork and procedures. The key concerns raised in this 26-page Form 483 range from issues such as the lack of established procedures to prevent microbiological contamination of drugs purporting to be sterile, to incomplete lab records, and inadequate validation of aseptic processes.

Shares of Aurobindo Pharma were trading 1.39% higher at ₹1,029.25 apiece on BSE at 2:18 pm.

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Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow