Tag: USFDA

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

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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

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

Lupin launches Ganirelix Acetate Injection in US for women undergoing fertility treatment

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

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Lupin Ltd announced on Thursday that it has launched Ganirelix Acetate Injection in the United States, indicated to inhibit premature luteinizing hormone surges in women.

The pharmaceutical company informed the stock exchanges that it has received approval from the United States Food and Drug Administration (USFDA) for launching the Ganirelix Acetate Injection in the country.

The US health regulator has approved the launch of the Ganirelix Acetate Injection in the dosage of 250 mcg/0.5 mL, in a single-dose prefilled syringe.

The injection is recommended in fertility treatment to prevent luteinizing hormone (LH) surges or ovulation in women undergoing controlled ovarian hyperstimulation.

The Ganirelix Acetate Injection is a generic equivalent of Ganirelix Acetate Injection in the same dose (250 mcg/0.5 mL), the reference listed drug (RLD) of the US-based pharma company Organon USA LLC.

As per IQVIA MAT data for December 2023, the Ganirelix Acetate Injection had an estimated annual sale of $87 million in the United States.

Last week, Lupin reported a 299.6% year-on-year (YoY) growth in net profit at ₹613.1 crore for the third quarter ended December 31, 2023, compared to ₹153.4 crore in the same period last year. Its revenue from operations grew 20.2% to ₹5,197.4 crore from ₹4,322.2 crore in the corresponding quarter of the previous fiscal year.

The company’s margin rose to 20% in Q3FY24, up from 12.3% in the same period last year.

Shares of Lupin were trading 0.63% lower at ₹1,599.5 apiece in BSE at 2:06 PM.

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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

Aurobindo Pharma under USFDA scrutiny: What investors need to know

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

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Aurobindo Pharma has come under the regulatory spotlight in the past two weeks as the company’s formulation manufacturing facility, Eugia Unit III, could be facing compliance issues. The US Food and Drug Administration (USFDA) issued nine observations after inspecting the Eugia Unit III plant from January 22 to February 2.

The plant is a part of Aurobindo Pharma’s speciality business, Eugia Pharma Specialities. The latest development is that the US federal regulator issued nine observations to the plant that manufactures sterile drugs such as injectables and ophthalmics.

According to experts, the observations point to 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.

Observations point to deficiencies in manufacturing practices and investors fear if there were questions around the data generated by the facility.

Aurobindo, in response to these findings, has taken proactive measures. The company announced during a recent call that it would submit its response on Eugia Unit 3 by February 26. Moreover, as a cautionary step, manufacturing operations in some lines at Eugia Unit 3 have been halted.

However, the company expects to resume non-aseptic line production in a few weeks and aseptic line production within a month. Unit 3 contributes significantly to Aurobindo’s Eugia business, which accounts for 40% of the company’s total revenue.

Aurobindo anticipates a potential impact of $20 million in the fourth quarter due to the shutdown of operations at Eugia Unit 3. However, the company does not anticipate major pending approvals from Eugia Unit III in FY25–26. Aurobindo anticipates sales from new launches in the near term to be between $35 and $40 million, with new launches from Eugia Unit 3 accounting for 50%, or approximately $20 million.

Despite these challenges, Aurobindo remains confident of achieving its 20% margin target, with growth in FY25–26 to be mainly driven by the Revlimid generic.

Analysts say the next port of call will be the company’s response to the observations and the USFDA’s classification of the plant, which is expected within three months of the inspection. If the plant is classified as an ‘official action indicated’, then the regulator could take adverse steps such as a warning letter that stops future approvals. In the worst-case scenario, it can issue an ‘import alert’ that stops all current manufacturing and future approvals.

In the event of an import alert, it could impact consolidated EBITDA by 15%, according to Elara, which maintains its buy call with a target price of ₹1,208.

Amid these developments, Aurobindo’s stock has corrected by around 16% since February 1, resulting in a reduction in the FY25 PE ratio to 14.7x, down from 17x on January 31.

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

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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

Aurobindo Pharma gets USFDA approval for muscular dystrophy tablets

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

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Aurobindo Pharma Limited shares closed higher on Monday after the company announced receiving the approval from the United States Food and Drug Administration (USFDA) for Deflazacort Tablets.

In a filing to the stock exchanges, the company said that the US drug regulator has issued approval for Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg.

Deflazacort Tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and above.

The approved drug has an estimated market size of $67 million for the three months ending September 2023, according to PTC Therapeutics Inc, the company informed the bourses.

The company now has a total of 502 ANDA approvals including 20 tentative approvals from USFDA.

Headquartered in Hyderabad, Aurobindo Pharma develops manufactures, and commercialises a wide range of generic pharmaceuticals, branded speciality pharmaceuticals and active pharmaceutical ingredients (APIs) globally in over 150 countries.

The company owns 25 manufacturing and packaging facilities, approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA.

Aurobindo Pharma shares showed strong consolidation on Monday, rallying over 3% in intraday trade after the company posted strong Q3 results.

The company’s net profit soared nearly 91% year-on-year to ₹936.2 crore for the December quarter. Its revenue was up by 14.7% YoY to ₹7, 351.7 crore.

The pharma company’s operational performance also improved as the EBITDA margin expanded to 21.8% from 14.9% in the year-ago period.

Aurobindo Pharma shares closed higher at ₹1,017.95 apiece, up 1.59%, on BSE.

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

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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

Neuralink Telepathy: All you need to know about first wireless brain chip implant

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

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Elon Musk’s neurotechnology company Neuralink has successfully implanted one of its wireless brain chips, named Telepathy, in a human for the first time.

Sharing the news on X, Musk said that initial results have detected promising neuron spikes or nerve impulses, while the patient is recovering well.

“The first human received an implant from @Neuralink yesterday and is recovering well. Initial results show promising neuron spike detection,” Musk said.

The first human received an implant from @Neuralink yesterday and is recovering well.

Initial results show promising neuron spike detection.

— Elon Musk (@elonmusk) January 29, 2024

Musk stated that the first Neuralink product has been named Telepathy and it “enables control of your phone or computer and through them almost any device, just by thinking.”

“Initial users will be those who have lost the use of their limbs. Imagine if Stephen Hawking could communicate faster than a speed typist or auctioneer. That is the goal,” he wrote.

The first @Neuralink product is called Telepathy

— Elon Musk (@elonmusk) January 29, 2024

Neurons, which the National Institutes of Health defines as cells that employ chemical and electrical signals to transfer information around the brain and to the body, are the source of spikes in activity.

Neuralink got permission to test the chip on humans by the United States Food and Drug Administration (USFDA) in May last year, which was a critical milestone for the company after earlier struggles to gain approval.

Through Telepathy, Musk’s company wishes to help patients overcome paralysis and a host of neurological conditions.

How does Neuralink Telepathy work?

According to Neuralink, the study involves a robot surgically implanting a brain-computer interface (BCI) implant in a part of the brain that governs the intention to move. Its primary objective is to allow people to operate a computer cursor or keyboard with just their thoughts.

The company stated that the ‘ultra-fine’ threads in its implant help in transmitting signals in the brain of the participant, Reuters reported.

To assess the safety of the implant and surgical robot, the company is conducting the PRIME Study for its wireless brain-computer interface.

Neuralink has been under pressure to examine its safety procedures. Recently, the US Department of Transportation (DOT) fined the company for violating regulations about the transportation of hazardous commodities.

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

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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

Lupin gets tentative USFDA nod for rivaroxaban tablets used to treat blood clots

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

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Pharma major Lupin received tentative approval from the United States Food and Drug Administration (USFDA) for rivaroxaban tablets on Tuesday, January 23.

Following the approval, the company released a statement, “(We) received tentative approval from the USFDA for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, to market a generic equivalent of Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc.”

The medicine, which has been tentatively approved by the USFDA, serves as a generic equivalent to Xarelto Tablets by Janssen Pharmaceuticals, Inc.

Rivaroxaban, which is used to prevent blood clots from forming due to an irregular heartbeat, will be manufactured at the company’s Pithampur facility in Madhya Pradesh.

Rivaroxaban tablets USP (RLD Xarelto®) had estimated annual sales of $8,249 million in the US as per IQVIA MAT November 2023. 

The medicine is used for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), in addition to reducing the risk of stroke, DVT, PE and recurrent VTE in paediatric patients from birth to less than 18 years, among a few other ailments.

Rivaroxaban tablets USP (RLD Xarelto®) had estimated annual sales of $8,249 million in the US as per IQVIA MAT November 2023, the company added.

Lupin has 15 manufacturing sites, seven research centres, and more than 20,000 professionals working globally, the company revealed.

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

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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 gets USFDA nod to make and market Parkinsons treatment drug

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

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The United States Food and Drug Administration (USFDA) has given its final approvals to Zydus Lifesciences to manufacture and market the Pimavanserin Capsules, 34 mg and Pimavanserin capsules Tablets, 10 mg, respectively, the pharma company informed the stock exchanges on Wednesday, January 17.

The drug is used for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, the company said.

Parkinson’s Disease (PD) is a progressive disorder which affects the nervous system, causing balance issues, slowed movements, rigidity, tremors, etc. As per the National Library of Medicine, US, PD psychosis is common among patients who are treated with dopaminergic drugs.

The Pimavanserin tablets and capsules will be manufactured at Zydus Life’s Ahmedabad SEZ manufacturing facility.

“Pimavanserin Capsules, 34 mg had annual sales of $149 million and Pimavanserin Tablets, 10 mg had annual sales of $10 million in the United States,” the company said.

As per the stock exchange filing, the group now has a total of 384 approvals and has filed for more than 448 Abbreviated New Drug Applications (ANDAs), till September 2023, since the commencement of the filing process in FY04.

Shares of Zydus Lifesciences ended 0.59% higher at ₹711 apiece on Wednesday, January 17.

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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

Lupin reports three USFDA approvals in less than a week

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

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The US Food and Drug Administration has approved Propranolol Hydrochloride Extended-Release Capsules (the generic version of Inderal sold by Minnesota-based ANI Pharmaceuticals) made by Lupin, the company said in a filing to the stock exchanges.

This new medicine helps in lowering blood pressure, relaxes the blood vessels in the brain and can prevent migraine headaches. This drug had an annual sales of $71 million in the US, according to data shared by the Mumbai-based drug maker.

It will release the drug (generic Inderal) in four strenghts: 60 milligram (mg), 80 mg, 120 mg, and 160 mg. This is third new launch announced by the company in the last one week.

The other two being Varenicline tablets (recommended in the treatment of smoking addictions and dry eye disease), and bromfenac ophthalmic solution (used to treat inflammation and pain among patients who have undergone cataract surgery).

Shares of Lupin have rallied over 84% in the last one year. In the first fortnight of 2024, investors in Lupin have seen their wealth go up by nearly 6%.

The company is targetting quarterly sales of $250 million in the next 3-4 years, global chief financial officer Ramesh Swaminathan told CNBC-TV18 in an interview on January 4.

In the financial year ending March 2023, the drug maker reported a revenue of $632 million from the US (out of a total revenue of $2 billion).

In the latest second quarter ended September 2023, for the first time in two years, Lupin crossed $200 million in revenue from North America, which made for 38% of the company’s total revenue.

Aside from the new drug approvals, Lupin shares are also cheering the easing stress on the company’s profit margin.

Despite being the third largest pharmaceutical company in the US (by prescriptions), increased competition, and rising cost of inputs, had squeezed the profit margin in recent years.

However, the growing belief on the street is that the margin squeeze is now over. In the first half of the current financial year ending March 2024, the company clocked an EBITDA margin of 19% compared to just 9% in the same period last year.

Global investment bank Nomura increased the target price on Lupin share to ₹1,593 from ₹1,290 per share earlier citing better earnings potential.

Earlier, on December 28, the Mumbai-based broking firm upgraded the rating on Lupin to ‘buy’ with a new target price of ₹1,440.

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