ZYDUSLIFE

Feb 12 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - ENTERS SETTLEMENT AGREEMENT WITH ASTELLAS OVER MYRBETRIQ

• ZYDUS LIFESCIENCES - TO PAY ASTELLAS USD 120 MILLION

• ZYDUS LIFESCIENCES - TO PAY LICENSING FEE ON GENERIC MIRABEGRON

• ZYDUS LIFESCIENCES - SETTLEMENT CONCLUDES LITIGATIONS, ZYDUS TO MARKET GENERIC MIRABEGRON

Source text: ID:nBSE4lWKCb

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Feb 9 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES Q3 CONSOL NET PROFIT 10.42 BILLION RUPEES; IBES EST. 9.32 BILLION RUPEES

• ZYDUS LIFESCIENCES Q3 CONSOL TOTAL REVENUE FROM OPERATIONS 68.65 BILLION RUPEES; IBES EST. 61.76 BILLION RUPEES

Source text: ID:nBSE2fz8FD

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Feb 4 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - ZYDUS RECEIVES TENTATIVE APPROVAL FROM USFDA FOR DAPAGLIFLOZIN TABLETS

• ZYDUS LIFESCIENCES - RECEIVES TENTATIVE APPROVAL FROM USFDA FOR DAPAGLIFLOZIN TABLETS, 5 MG AND 10 MG

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Jan 23 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• USFDA INSPECTION CLOSED AT ZYDUS UNIT-2 PLANT IN ANKLESHWAR

• INSPECTION CONCLUDED WITH 3 OBSERVATIONS

Source text: ID:nBSE42WxM

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Jan 22 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - LAUNCHES BIOSIMILAR OF NIVOLUMAB IN INDIA

• ZYDUS LIFESCIENCES - BIOSIMILAR TISHTHA PRICED AT 28,950 RUPEES FOR 100 MG AND 13,950 RUPEES FOR 40 MG

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Adds background throughout, shares in paragraph 2

Jan 13 (Reuters) - The U.S. Food and Drug Administration approved Fortress Biotech FBIO.O and Indian drugmaker Zydus Lifesciences' ZYDU.NS drug for children with a rare genetic disorder that impairs copper absorption, Fortress said on Tuesday.

Shares of Fortress Bio rose more than 13% in premarket trading.

The drug, branded as Zycubo, is approved to treat Menkes disease, where patients are born without the ability to absorb copper from their diet. It is caused by mutations in a particular gene that is responsible for the transport of copper throughout the body.

The approval makes it the first drug on the market to treat this disease in the United States.

Symptoms of this condition include sparse and de-pigmented hair, seizures and developmental delays. If left untreated, many patients die between the ages of two and three years.

The disease primarily affects male infants. According to the companies, recent estimates suggest a prevalence of 1 in 34,810 to as high as 1 in 8,664 live male births.

Fortress is eligible to receive tiered royalties on net sales of Zycubo and up to $129 million in aggregate development and sales milestones from Zydus.

The drug, chemically known as CUTX-101, is an under-the-skin injectable formulation of copper histidinate, a copper replacement that can be injected directly into the body to avoid absorption through the gastrointestinal tract.

It helps increase copper levels in the blood, to improve body and brain function.

The approval was based on data showing Zycubo improved overall survival in patients who received early treatment, with a nearly 80% reduction in the risk of death compared with those who were untreated.

Current treatments include daily copper injections.

(Reporting by Padmanabhan Ananthan and Sneha S K in Bengaluru; Editing by Devika Syamnath)

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Jan 9 (Reuters) - FDA:

• FDA APPROVES FIRST GENERIC ROBENACOXIB TABLET FOR POSTOPERATIVE PAIN & INFLAMMATION IN CATS

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Dec 30 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• GETS TAX DEMAND ORDER OF 28 MILLION RUPEES

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Oct 6 (Reuters) - Zydus Lifesciences ZYDU.NS:

• RECEIVES HEALTH CANADA APPROVAL FOR LIOTHYRONINE TABLETS

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Oct 1 (Reuters) - The U.S Food and Drug Administration on Wednesday declined to approve Fortress Biotech FBIO.O and Indian drugmaker Zydus Lifesciences' ZYDU.NS drug for a type of rare genetic disease in children, Fortress said.

(Reporting by Padmanabhan Ananthan and Sneha S K in Bengaluru; Editing by Vijay Kishore)

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Sept 5 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - CLOSURE OF USFDA INSPECTION AT ZYDUS’ INJECTABLE MANUFACTURING PLANT AT JAROD

• ZYDUS LIFESCIENCES - USFDA INSPECTION CONCLUDED WITH 4 OBSERVATIONS

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Sept 4 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS AND SYNTHON ENTERED INTO EXCLUSIVE LICENSING AND SUPPLY AGREEMENT

• AGREEMENT FOR OZANIMOD CAPSULES FOR THE U.S. MARKET

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July 16 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• USFDA CLOSES REMOTE REGULATORY ASSESSMENT AT MATODA FACILITY

• NO OBSERVATIONS NOTED; SITE RECOMMENDED FOR APPROVAL

Source text: ID:nNSE9CCP9B

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June 18 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• CLOSURE OF USFDA INSPECTION AT ZYDUS’ ONCOLOGY INJECTABLE PLANT AT AHMEDABAD

• INSPECTION IS CLOSED WITH 2 OBSERVATIONS

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June 3 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ENTERED INTO DEFINITIVE AGREEMENT WITH AGENUS WEST LLC, AND AGENUS INC., USA

• AGREEMENT TO ACQUIRE TWO U.S. BASED BIOLOGICS MANUFACTURING FACILITIES OF AGENUS

• DEAL FOR UPFRONT CONSIDERATION OF USD 75 MILLION

• CONTINGENT PAYMENT OF UP TO USD 50 MLN OVER 3 YEARS

Source text: ID:nnAZN3XL2JS

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May 20 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES LTD - NITIN PAREKH TO SUPERANNUATE AS CFO EFFECTIVE AUGUST 31, 2025

• ZYDUS LIFESCIENCES LTD - TUSHAR SHROFF APPOINTED AS CFO EFFECTIVE SEPTEMBER 1, 2025

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Adds analyst comment in paragraph 6-7, updates shares

May 12 (Reuters) - Indian pharma stocks .NIPHARM fell 1.6% on Monday, bucking broader market gains, after U.S. President Trump said he would cut drug prices by 30%–80% to match other wealthy nations.

Trump said he would sign an executive order on Monday to pursue "most favored nation" pricing.

The U.S. currently pays nearly three times more for many prescription drugs, though Trump offered no implementation details. Several Indian drugmakers earn a significant share of their revenue from North America by selling low-cost generic versions of newer drugs.

Thirteen of 20 stocks on the pharma sub-index fell, led by Sun Pharma’s 4.6% drop, even as the Nifty 50 .NSEI gained 2.5%; Zydus Life ZYDU.NS and Cipla CIPL.NS also declined 0.7% each.

Divi's Laboratories DIVI.NS and Lupin LUPN.NS fell 2% each, while Biocon BION.NS lost nearly 3%.

"A price cut of prescription drugs by 50% or more would hurt the U.S. formulations market, more on the branded size due to immediate potential impact, while over the medium term it will also impact generics as it reduces the potential market size of new drugs," said Shrikant Akolkar, an analyst at Nuvama Institutional Equities.

"Indian branded players like Sun Pharma, Biocon and Zydus Life may see an impact upon strict implementation," Akolkar said.

The U.S. accounts for nearly a third of India's pharma exports, which rose 16% to about $9 billion last fiscal year, according to government-backed trade body Pharmexcil.

(Reporting by Kashish Tandon in Bengaluru; Editing by Nivedita Bhattacharjee and Mrigank Dhaniwala)

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April 25 (Reuters) - Amplitude Surgical SA AMPLI.PA/ZYDUS LIFESCIENCES:

• ZYDUS LIFESCIENCES LIMITED SIGNS PURCHASE AGREEMENT WITH PAI PARTNERS AND OTHER SHAREHOLDERS TO ACQUIRE A MAJORITY STAKE IN AMPLITUDE SURGICAL SA

• Zydus has signed the share purchase agreement to acquire 75.4% of the share capital of Amplitude1 at a price of €6.25 per Amplitude share from PAI Partners, Olivier Jallabert and other managers of Amplitude

• SUBJECT TO FULFILMENT OF CLOSING CONDITIONS, ZYDUS WILL ACQUIRE 85.6% OF SHARE CAPITAL OF AMPLITUDE.

Source text: ID:nBw8Q0mba

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(Reporting by Sudip Kar-Gupta)

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April 17 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS MEDTECH TO MARKET TAVI TECHNOLOGY IN INDIA, EUROPE

• ZYDUS MEDTECH PARTNERS WITH BRAILE BIOMEDICA TO COMMERCIALIZE TAVI

Source text: ID:nBSE2bMbGC

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April 16 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• US COURT RULES AGAINST ZYDUS IN PATENT LITIGATION

• EVALUATING IMPACT AND LEGAL REMEDIES OF COURT ORDER

Source text: ID:nBSEcdr2FK

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Adds analyst comments in paragraphs 11-12, updates share moves throughout

By Manas Mishra and Ananta Agarwal

April 9 (Reuters) - Global drugmakers' stocks dropped across the board after U.S. President Donald Trump reiterated plans for a "major" tariff on pharmaceutical imports, threatening an interwoven global supply chain, and as his country-specific reciprocal tariffs took effect, leading to more pain in global markets.

Pharmaceutical imports were initially exempt from Trump's first set of reciprocal tariffs last week — but his administration has since indicated that levies on the sector, which in the past has been excluded from such actions, are coming.

The U.S. president has said the tariffs will incentivize drug companies to move operations to the United States. However, analysts and companies have raised concerns about the difficulty in setting up manufacturing in the country.

Shares of major U.S. drugmakers Amgen AMGN.O, AbbVie ABBV.N, Pfizer PFE.N, Merck MRK.N and Eli Lilly LLY.N fell between 3% and 6% in premarket trading.

In Europe, a basket of healthcare stocks .SXDP fell 5% to its lowest since October 2022, leading losses among sectoral indexes on the region-wide STOXX 600 .STOXX, which was down 3.3% at 1013 GMT. The index was heading for its biggest one-day drop since March 2020.

Trump had also threatened the duties on Friday after his first set of "reciprocal" tariffs exempted pharma products. Trump has not said when and by how much he plans to raise levies on pharma imports.

"While the details are scant, we are strongly opposed to tariffs on any pharmaceuticals — these will likely do little to shift manufacturing back to the U.S.," said BMO Capital Markets analyst Evan Seigerman.

"Given the complexity of the pharma supply chain, we do not expect the industry to make any major changes. These current tariffs are being pursued under emergency powers, which at worse will last until the end of the current administration and could end sooner with an act of Congress."

Seigerman also pointed to concerns over recent layoffs at the U.S. Food and Drug Administration, saying the worries were now compounded by the "real talk" of pharma tariffs.

ADDITIONAL COSTS, LONG WAIT FOR PRODUCTION

Europe and the U.S. have interconnected supply chains for medicines. The United States depends on medicines partly produced in Europe that bring in hundreds of billions of dollars in revenue.

Bernstein analyst Courtney Breen wrote in a note that her worst-case scenario assumes tariffs could be steep, leading to about $53 billion in additional costs paid for pharmaceutical imports.

If companies did choose to bring new manufacturing to the United States, Breen expects additional spend of $2 billion for each new "green field" site and a five-year runway to production.

EU medical and pharmaceutical product exports to the U.S. totaled about 90 billion euros ($97 billion) in 2023, according to latest Eurostat data.

Shares of AstraZeneca AZN.L, GSK GSK.L, Roche ROG.S, Sanofi SASY.PA and Novartis NOVN.S fell between 5% and 6.5% in Europe. Meanwhile, Indian pharmaceutical stocks .NIPHARM closed nearly 2% lower, dragging down the benchmark Nifty 50 .NSEI by 0.6%.

IPCA Laboratories IPCA.NS, Glenmark Pharma GLEN.NS and Biocon BION.NS were the top losers by percentage on the pharma index in Mumbai, ending the trading session between 4% and 5.5% lower.

India's pharma exports to the U.S. mostly comprise generics, or cheaper versions of popular drugs. The United States accounts for a third of India's overall pharma exports.

(Reporting by Kashish Tandon, Ananta Agarwal and Manas Mishra in Bengaluru and Anna Pruchnicka in Gdansk; Editing by Savio D'Souza, Mrigank Dhaniwala and Shounak Dasgupta)

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March 28 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - EXTEND CLOSE OF DEAL WITH STERLING BIOTECH TO SEPTEMBER 30, 2025

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March 20 (Reuters) - Eli Lilly LLY.N on Thursday launched in India its diabetes and weight-loss drug, Mounjaro, which has already clocked in over $20 billion in global sales since its initial U.S. launch in 2022.

India, the world's most populous country, has high obesity rates and the second-highest number of people with type 2 diabetes. Around 11% of Indian adults are expected to become obese by 2035, according to the World Obesity Federation Atlas.

Here are the local and international drugmakers also eyeing the Indian market and looking to introduce rivals to Lilly's drug:

NOVO NORDISK

The Danish drugmaker NOVOb.CO had said it aims to launch its blockbuster weight-loss drug, Wegovy, in India by 2026.

The active ingredient in Wegovy is semaglutide, which is likely to go off-patent in 2026 in India.

Wegovy and Lilly's Mounjaro belong to the same class of treatments called GLP-1 agonists, which soared into popularity globally triggering a shortage of supply. GLP-1 drugs mimic a gut hormone that helps control blood sugar levels and slow digestion, making people feel fuller for longer.

SUN PHARMA

Sun Pharmaceutical SUN.NS, India's largest drugmaker by revenue, is developing its own GLP-1 treatment, utreglutide, for weight loss and type 2 diabetes.

The drugmaker said earlier this month it expects to launch the drug in the next four to five years.

BIOCON

Indian drugmaker Biocon BION.NS is developing its own version of Novo's Wegovy, as the drug is set to lose exclusivity next year in emerging markets such as India, Brazil, Mexico, and Saudi Arabia.

ZYDUS LIFESCIENCES

India's Zydus Lifesciences ZYDU.NS is developing the generic version of Semaglutide and plans on launching the drug after its patent expires in India.

CIPLA

Cipla CIPL.NS, India's third-largest drugmaker by sales, is among the Indian drugmakers making cheaper versions of Novo's Wegovy.

Cipla has also said it is open to partnering with Lilly to market Mounjaro in India.

DR. REDDY'S

India's Dr. Reddy's REDY.NS has said it plans to launch generic versions of Semaglutide in all the markets as Novo's patent expires.

LUPIN

India's Lupin LUPN.NS is another generic drugmaker looking to grab a share of the burgeoning obesity treatment market with its own version of Novo's Wegovy.

NATCO, MANKIND PHARMA, AUROBINDO PHARMA

Media reports say India's Natco Pharma NATP.NS, Mankind Pharma MNKI.NS, Aurobindo Pharma ARBN.NS are also developing cheaper versions of Novo's Wegovy.

Reuters was not able to independently verify the reports.

(Reporting by Mariam Sunny in Bengaluru; Editing by Maju Samuel)

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March 12 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS RECEIVES FINAL APPROVAL FROM USFDA FOR METHENAMINE HIPPURATE TABLETS

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March 11 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES LTD - TO ACQUIRE 85.6% STAKE IN AMPLITUDE SURGICAL

• ZYDUS LIFESCIENCES LTD - ACQUISITION PRICE EURO 6.25 PER SHARE, TOTAL VALUE EURO 256.8 MILLION

• ZYDUS LIFESCIENCES LTD - PLANS TO DELIST AMPLITUDE SURGICAL AFTER ACQUISITION

• ZYDUS LIFESCIENCES LTD - TOTAL CONSIDERATION FOR 100% EQUITY SHARE CAPITAL EURO 300 MILLION

Source text: ID:nBSE2njy48

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March 5 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - LAUNCHES ANVIMO, FOR TRANSPLANT PATIENTS FOR INDIA

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March 4 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• TO DEVELOP COMBINATION VACCINE TO PROTECT AGAINST SHIGELLOSIS, TYPHOID FOR INFANTS, CHILDREN

• PROJECT SUPPORTED BY GATES FOUNDATION TO START IN MARCH 2025

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March 3 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - PENALTY OF 4.27 MILLION RUPEES IMPOSED ON ZYDUS HEALTHCARE

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