
U.S. FDA nod for Lupin's generic of Janssen Pharma's blood thinner tablets
The product will be manufactured at its Aurangabad facility. The approved product had an estimated annual sales of $8,052 million in the U.S., Lupin said citing IQVIA MAT March 2025 numbers. Rivaroxaban Tablets USP are indicated to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation and for treatment of deep vein thrombosis as well as pulmonary embolism, it said.
Rivaroxaban Tablets are bioequivalent to Xarelto, which Jannsen said is a blood thinner to treat and help prevent blood clots related to certain conditions involving the heart and blood vessels.
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Time of India
8 hours ago
- Time of India
European shares flat as investors await Ukraine talks
European shares were little changed in early trade on Monday, with investors on the watch for Ukraine and European leaders' meeting with U.S. President Donald Trump , following a Russia-U.S. summit that ended without an immediate agreement. The pan-European STOXX 600 index were flat, as of 0704 GMT, after logging a second straight weekly gain on Friday. Ukraine's Volodymyr Zelenskiy will meet Trump along with other European leaders in a bid to draw out a peace deal that will not favour Moscow. Trump met with his Russian counterpart Vladimir Putin on Friday and agreed that a peace deal should be worked upon without a ceasefire. Novo Nordisk added 4.1% after the drugmaker' s weight-loss drug Wegovy received an accelerated approval by the U.S. Food and Drug Administration to treat a serious liver condition. Live Events Vestas shares jumped 9.7% and ranked among the top gainer on the STOXX 600 after IRS safe harbor guidelines. Commerzbank fell 3.7%, after Deutsche Bank cut the stock's rating to "Hold" from "Buy".


Time of India
15 hours ago
- Time of India
An Unclaimed Legacy: Who after Rakesh Jhunjhunwala?
Mumbai: It's been three years since Rakesh Jhunjhunwala , India's best-known individual investor , passed away. Last week, seasoned Dalal Street participants paid rich tributes to the late billionaire investor, reminiscing about the heady mix of earthy wisdom, tenacity, and pluck-bordering on daredevilry-that catapulted Jhunjhunwala to legendary status. But, in an industry obsessed with the next big thing, few had a clear answer to the question: Who can fill the space Jhunjhunwala left behind? Jhunjhunwala's scale as an individual investor remains unmatched even today. The numbers tell the story. As of June 30, the family's listed portfolio, overseen by his wife Rekha, was worth over ₹64,000 crore or about $7.8 billion. Other families too have amassed enormous wealth in recent years, but few had captured the imagination of the common man the way Jhunjhunwala did, thanks to his larger-than-life public persona. Most of this wealth has been created in the past two decades, aided by early bets in the once-ignored stocks such as Titan and Lupin. Today's investing bigwigs continue to follow that playbook, scoping up overlooked micro-cap stocks and holding them until they become market darlings. The strategy has paid off handsomely in recent years as Indian markets have risen from strength to strength, resulting in most stocks delivering dizzying returns. The question then is: Why haven't their portfolios caught up with Jhunjhunwala's? One big differentiator is leverage. Jhunjhunwala often buttressed his trading and investments with sizable borrowed money that increased his buying power and magnified the returns. Live Events "Rakesh was extremely gutsy and came from a generation that used leverage liberally," said seasoned investor Shankar Sharma. "Now who would dare to build a big position in a stock (Titan) in 2003, with leverage, just after going through a rough patch before that?" Most big investors these days avoid aggressive investment bets with borrowed money. When they do use leverage, it is mostly confined to their trading portfolio, which is usually just a fraction of their long-term holdings. While that has shielded them from sharp drawdowns, it has also capped the potential of outsized gains. Their restraint with leverage reflects a preference for peace of mind over the mental strain of borrowed bets, choosing a quieter life over elevated risk-taking. By contrast, Jhunjhunwala was cut from a different cloth-willing to embrace risks that few others dared to take on. In a way, leverage was his sharpest weapon and the hardest one to replicate. "Like Jacques Kallis (the former South African cricketer), he was an all-rounder par excellence in long-term investing, trading and risk-taking across asset classes-a combination that will be near impossible to emulate," said Nilesh Shah, managing director, Kotak Mutual Fund. Skills apart, timing and luck mattered too. It was also about being at the right place at the right time, a factor that even Warren Buffett has credited for his wealth creation. The foundation for the Jhunjhunwala family's wealth today was laid nearly two decades ago when the Sensex was between 5,000 and 20,000. Back then, market inefficiencies priced some of the future winners at throwaway prices, while lax corporate governance standards meant information was always skewed, giving a set of market participants an edge. Now, with the index at 80,000, a lot of those inefficiencies have been eliminated in the face of a wider set of institutional and retail investors, along with a far tighter regulatory regime. As valuations remain rich across the board and bear markets become shorter, the scope for building fortunes from contrarian bets has narrowed considerably. "It will be very difficult for anybody in the current generation to replicate that success purely from investing because it came from a confluence of events," Sharma said. "In theory, replicating Rakesh's success is doable but you can't use the same playbook for that because economic realities have undergone a change." In cricket, the saying goes that records are meant to be broken. In investing though there are no records, only shifting goalposts. The best that today's investors could do is buy potential winners with the hope that one of them is the next Titan without expecting to become the next Jhunjhunwala. "What people must understand is that Rakesh Jhunjhunwala's astounding success is a freak case. It's not realistic because his Titan bet was an outlier," said Sharma. "When a large leveraged dominant trade works out, it's genius. But what if it doesn't? Are you prepared for the cost of it all?"


The Hindu
a day ago
- The Hindu
Precigen shares jump after U.S. FDA approves first therapy for rare respiratory disease
Precigen's immunotherapy for a rare respiratory disease has become the first treatment to win U.S. regulatory approval for the condition, which typically requires frequent surgeries, sending the company's shares soaring 83% on Friday. The U.S. Food and Drug Administration has approved the therapy, Papzimeos, to treat adults with recurrent respiratory papillomatosis (RRP) — a condition that causes growth of benign tumors in the respiratory tract due to human papillomavirus (HPV) infection. A distinguishing aspect of RRP is the tendency for the tumors to return even after removing them through surgical procedures. The disease can be fatal as there is no cure. The FDA approval was based on an early-to-mid-stage study data that showed 51% of patients required no surgeries in the 12 months after the treatment. "Randomised trials are not always needed to approve medical products and this approval is proof of that philosophy," said Vinay Prasad, who recently returned to the FDA to oversee vaccine, gene therapy and blood product regulation. Papzimeos is designed to stimulate an immune response against cells infected with HPV types 6 and 11 — the strains that cause the disease. H.C. Wainwright analysts estimate peak sales of the drug to reach $1.1 billion in 2033. "We may finally be able to say no more surgery," said Kim McClellan, president of the Recurrent Respiratory Papillomatosis Foundation. McClellan herself was diagnosed with RRP at the age of five and has since then had more than 250 surgeries. Precigen estimates about 27,000 adult RRP patients in the U.S. It did not immediately respond to a Reuters request for comment on the treatment's pricing. Simon Best, associate professor of Otolaryngology at Johns Hopkins Hospital, said patients were eagerly awaiting a new treatment. "There's nothing more frustrating than doing a surgery and then having the patient come back six months later."