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☆ Guggenheim lures Greenhill's dealmakers to expand into Europe, sources say
▼ + stars: | 2023-04-20 | by ( Andres Gonzalez | ) www.reuters.com time to read: +1 min

LONDON, April 20 (Reuters) - U.S. investment bank Guggenheim Securities will begin its European expansion by hiring four senior bankers from Greenhill, three sources familiar with the matter told Reuters. Guggenheim already had a small group of bankers covering European deals, one of the sources said. The Wall Street bank has snapped up Greenhill & Co.'s telecoms and digital infrastructure team, led by Jonathan Dann and Pieter-Jan Bouten, the sources said on condition of anonymity. Investment bankers Charlie Evans and Achille Del Pizzo will also move to Guggenheim, where the team will begin in May. Guggenheim, which according to Refinitiv ranked 39th among global M&A advisers in 2022, in the first quarter advised on Pfizer Inc.'s $43 billion deal to acquire Seagen Inc.

[1/2] Sanofi logo at the company's headquarters during the annual results news conference in Paris, France, February 4, 2022. Sanofi in 2009 acquired the rights to Auvi-Q, an epinephrine auto-injector intended to compete with EpiPen. Injection of epinephrine is used to treat serious and sometimes life-threatening allergic reactions to foods, medications, bee stings and other causes. Circuit Court of Appeals last July agreed, noting that the exclusive contracts in question were "a normal competitive tool within the epinephrine auto-injector industry." The 10th Circuit added that Sanofi could have competed on those terms, but instead chose initially to market Auvi-Q as a more expensive, premium product.

☆ Novavax cut $50 million in costs, plans to slash more, CEO says
▼ + stars: | 2023-04-12 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

April 12 (Reuters) - Novavax Inc (NVAX.O) cut about $50 million in costs in the first quarter of 2023 and plans to slash more, Chief Executive John Jacobs said in an interview on Wednesday. “We’re looking at everything from buildings, leases, land, headcount, and contractors, every aspect of our company and the way we work,” he told Reuters. Jacobs said Novavax would seek funding for its COVID/influenza combination shot, including a potential partnership, depending on whether the upcoming data is positive. The CEO added that the company did not expect to launch its individual flu vaccine this year, and will focus on the COVID vaccine. Global regulators expect vaccination campaigns to be conducted once a year, similar to annual flu inoculations.

[1/4] A pack of birth control pills is displayed in this illustration picture taken in Philadelphia, Pennsylvania, U.S., July 11, 2022. REUTERS/Hannah Beier/IllustrationApril 10 (Reuters) - Over 300 biotech and pharmaceutical industry executives, including Pfizer Inc (PFE.N) CEO Albert Bourla, signed an open letter on Monday calling for reversal of a federal judge's decision to suspend sales of the abortion pill mifepristone. Last week's ruling by Judge Matthew Kacsmaryk undermines the FDA's authority, the letter's authors wrote, adding that it ignores decades of scientific evidence and legal precedent. The ruling could open the possibility to the banning of vaccines and contraception for women, said Levin. "It's the single worst threat to the industry in over 50 years."

☆ RSV cases in US show signs of return to pre-pandemic seasonality - CDC
▼ + stars: | 2023-04-06 | by ( ) www.reuters.com time to read: +2 min

April 6 (Reuters) - Respiratory syncytial virus (RSV) circulation is showing signs of return to pre-pandemic seasonality in the U.S. after two years of irregular onsets and peaks, the Centers for Disease Control and Prevention (CDC) said on Thursday. Typically, cases of RSV virus that can cause severe illness or death in the very young and old rose in October before waning in April. The varying timing could be challenging for drugmakers racing to get their RSV vaccines to the market. In both pre-pandemic and pandemic periods, RSV cases began to surge earlier in Florida and the Southeast and later in regions further north and west, the researchers said. "Policy makers should consider RSV seasonality when making recommendations about the timing of studies and administration of new immunization and other RSV prevention products," the report said.

And that has the impact of postponing some announcements," said Anu Aiyengar, global head of M&A at JPMorgan Chase & Co (JPM.N). M&A volumes dropped 44% to $282.7 billion in the U.S. and 70% to $81.87 billion in Europe. Reuters Graphics"Having a well-functioning financing market is a critical ingredient for M&A. Global M&A volumes in Q1 2023LACK OF CONFIDENCEThe depressed market valuations also presented an opportunity for prominent activist investors to launch new proxy fights, with dealmakers anticipating a boost to M&A volumes from activist campaigns in the coming quarters. "Inflationary pressures aren't subsiding as fast as people expected; there's still a lot of geopolitical tensions, and in a lot of ways, the disruption in the financing market is intensifying," Langston said.

March 30 (Reuters) - A federal judge in Texas on Thursday blocked Obamacare's mandate that health insurance plans cover pre-exposure prophylaxis against HIV (PrEP) and other preventive care including cancer and diabetes screenings. U.S. District Judge Reed O'Connor in Fort Worth, Texas, said the PrEP mandate violated a federal religious freedom law and that the other preventive care mandates were based on recommendations by an illegally appointed task force. The ruling was a victory for conservative businesses and individuals that sued to challenge the mandates in 2020. The U.S. Department of Health and Human Services, which oversees Obamacare, did not immediately respond to a request for comment. Reporting By Brendan Pierson in New York; Editing by Mark PorterOur Standards: The Thomson Reuters Trust Principles.

☆ Exclusive: ICU Medical to compete against GE Healthcare for Medtronic units -sources
▼ + stars: | 2023-03-29 | by ( David Carnevali | ) www.reuters.com time to read: +2 min

GE Healthcare and private equity firms Carlyle Group Inc (CG.O) and Clayton, Dubilier & Rice (CD&R), which have been pursuing rival offers separately, are also through to the second round, the sources added. Carlyle is bidding through its newly formed healthcare investment platform Atmas Health, according to one of the sources. Medtronic has been taking offers for its patient monitoring and respiratory interventions businesses even as it presses on with preparations to spin them off to its shareholders. ICU Medical, GE Healthcare, Carlyle and CD&R declined to comment. The patient monitoring technology portfolio includes Nellcor pulse oximetry and BIS brain monitoring, while the respiratory interventions business comprises ventilators and breathing systems.

☆ Chinese Authorities Raid Office of U.S. Investigations Firm Mintz Group
▼ + stars: | 2023-03-24 | by ( James T. Areddy | ) www.wsj.com time to read: 1 min

The closed office of the Mintz Group in a Beijing office building on Friday. The due diligence firm said five Chinese nationals employed in the office were detained without notice. NEW YORK—Authorities this week raided the Beijing offices of Mintz Group, detaining all five of the New York-based due diligence company’s staff members in mainland China, an incident likely to unnerve global businesses operating in the country. The move comes as the heads of multinational companies including Apple Inc. and Pfizer Inc. are due to arrive in Beijing to meet with top Chinese officials. This weekend’s China Development Forum will be the first to be held fully in-person since the Covid-19 pandemic broke out, and is just weeks after Beijing installed a slate of new government leaders as it signals fresh efforts to boost foreign investment.

The trial will be the first test of how Zantac cancer claims will fare before a jury. GSK said in a statement it disagreed with the ruling and would defend the case at trial. Originally marketed by a forerunner of GSK, it was later sold successively to Pfizer (PFE.N), Boehringer Ingelheim and finally Sanofi (SASY.PA). While NDMA is found in low levels in food and water, it is known to cause cancer in larger amounts. Analysts said it was not surprising that Grillo ruled differently from the federal court because California's courts are known to be friendlier to plaintiffs.

☆ US declines to force lower price on cancer drug Xtandi
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

WASHINGTON, March 21 (Reuters) - The U.S. government will not force Pfizer Inc (PFE.N) and Astellas Pharma Inc (4503.T) to lower the price of their prostate cancer drug Xtandi using its emergency "march-in" authority, the National Institutes of Health (NIH) said on Tuesday. Patient group the Union for Affordable Cancer Treatment first filed a petition calling on the NIH to use its authority to lower the drug's price in March 2016. The NIH said in a letter made public on Tuesday that its analyses in response to the petition found the prostate cancer treatment was widely available. "NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug," the letter said. Progressive lawmakers in the Democratic Party have been calling on President Joe Biden's administration to use its march-in authority to lower drug prices.

☆ Moderna expects to price its COVID vaccine at about $130 in the US
▼ + stars: | 2023-03-21 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

REUTERS/Hannah BeierMarch 20 (Reuters) - Moderna Inc (MRNA.O) expects to price its COVID-19 vaccine at around $130 per dose in the U.S. going forward as purchases move to the private sector from the government, the company’s president Stephen Hoge said in an interview on Monday. Hoge said the government's Medicare health plan for seniors pays $70 per dose for the seasonal influenza vaccine. Sanders, chair of the Senate’s powerful Health, Education, Labor and Pensions Committee, has said Moderna should not raise the price of its vaccine because of the government funding it received. He plans to question Moderna Chief Executive Stephane Bancel on the price increase at the hearing on Wednesday. Moderna in February forecast significantly declining 2023 COVID-19 vaccine sales, which reached $18.4 billion in 2022.

☆ FDA says Pfizer COVID pill EUA for adolescents to stay even after nod for adults
▼ + stars: | 2023-03-16 | by ( ) www.reuters.com time to read: +1 min

Companies Pfizer Inc FollowMarch 16 (Reuters) - The U.S. health regulator said on Thursday the current emergency use authorization (EUA) for Pfizer's COVID-19 antiviral pill for high-risk adolescents will continue to remain in effect even if it receives full approval for use in some adults. Paxlovid has been authorized for emergency use in mild-to-moderate COVID patients aged 12 years and older since late 2021, but Pfizer's application for full approval only covers high-risk adults. "Should this new drug application be approved, FDA anticipates that the EUA for Paxlovid will remain in effect to continue authorizing treatment of adolescents with mild-(to-)moderate COVID-19 and further address other access needs," the regulator added. A full approval would provide doctors more flexibility in prescribing the drug and also allow the company to expand its advertising campaign. Reporting by Leroy Leo and Khushi Mandowara in Bengaluru; Editing by Saumyadeb Chakrabarty and Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

☆ U.S. FDA advisers vote in favor of full approval for Pfizer's COVID pill Paxlovid
▼ + stars: | 2023-03-16 | by ( ) www.reuters.com time to read: 1 min

Companies Pfizer Inc FollowMarch 16 (Reuters) - Advisers to the U.S. health regulator on Thursday voted in favor of recommending a full approval for Pfizer's (PFE.N) COVID-19 pill Paxlovid in adults at high risk of progression to severe disease. The Food and Drug Administration's panel of external advisers voted 16-to-1 in favor of the drug's benefits outweighing its risk for some adults with mild-to-moderate COVID-19. Reporting by Leroy Leo and Khushi Mandowara in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ Pfizer to replace migraine drug packaging over child safety concerns
▼ + stars: | 2023-03-16 | by ( ) www.reuters.com time to read: +1 min

[1/2] The Pfizer logo is pictured on their headquarters building in the Manhattan borough of New York City, New York, U.S., November 9, 2020. REUTERS/Carlo Allegri/File PhotoCompanies Pfizer Inc FollowMarch 16 (Reuters) - Pfizer Inc (PFE.N) said on Thursday it was working on a new child-proof packaging for its migraine drug, Nurtec ODT, after safety concerns led to a recall alert from the U.S. Consumer Product Safety Commission (CPSC). Pfizer said it was developing a new packaging for the drug acquired through its $11.6 billion buyout of Biohaven Pharmaceutical Holding in 2022. As an interim measure, the company has instructed pharmacists to place the drug packet in a child-resistant vial before dispensing it to patients. The orally disintegrating tablets are used for the treatment of acute migraine and as preventive treatment for episodic migraine in adults.

☆ U.S. FDA expands authorization of Pfizer bivalent COVID-19 shots in kids
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +1 min

March 14 (Reuters) - Pfizer Inc (PFE.N) said on Tuesday that the U.S. Food and Drug Administration had expanded the emergency use authorization (EUA) of the company and its partner BioNTech SE's (22UAy.DE) bivalent COVID-19 vaccine as a single booster dose in certain children. The amended authorization is for children six months through four years of age who have completed their initial three-dose vaccination with Pfizer's original shot. In December, the U.S. health regulator had authorized Pfizer/BioNTech's updated shot as a third dose to those aged six months through four years, who have not completed their primary vaccination series or are yet to receive the third dose. Shots for youngest children in the United States were only approved in June last year, making them the last group to become eligible for vaccination. Reporting by Pratik Jain; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ Pfizer agrees to revise EU COVID vaccine contract -FT
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +2 min

[1/2] Pfizer company logo is seen at a Pfizer office in Puurs, Belgium, December 2, 2022. Under the revised terms, Pfizer is asking for payment for doses ordered that will never be manufactured, the FT report said. Medzhidiev added that he believed other EU members also would not support the proposed deal in its current form. "The proposed Pfizer amendment to the Pfizer agreement is clearly unacceptable to us given the critical situation of vaccine oversupply in Bulgaria and unjustified financial burden for products destined for destruction," Medzhidiev said. The discussions included the possibility that Pfizer would reduce the up to 500 million COVID-19 vaccine doses the EU has committed to buy this year in return for a higher price.

The Food and Drug Administration made its assessment in briefing documents ahead of a meeting of the agency's external advisers on Thursday to discuss full approval to use Pfizer's oral pill for high-risk COVID-19 patients exhibiting mild to moderate symptoms. Paxlovid has been authorized for emergency use since late 2021, and a full approval is likely to allow Pfizer to expand its advertising campaign for the drug. Over 12 million courses have been delivered to pharmacies, and patients have used over 8 million courses of the treatment, according to Federal data. Paxlovid has shown reduction in risk of hospitalization or death by 86% in non-hospitalized, high-risk adult patients in Pfizer' study, which did not include vaccinated participants. Reporting by Leroy Leo and Khushi Mandowara in Bengaluru; Editing by Shailesh Kuber and Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Sliding bank shares drag Wall Street down in choppy trade
▼ + stars: | 2023-03-13 | by ( David Carnevali | ) www.reuters.com time to read: +4 min

But many speculated the central bank could now become less hawkish, and the yield on the 2-year Treasury tumbled. Shares of SVB's peer Signature Bank (SBNY.O), which was also shut down by regulators, were halted. Weighing on the S&P 500, Charles Schwab (SCHW.N) tumbled 11.56% upon resuming trade after the financial services company reported a 28% decline in average margin balances and a 4% fall in total client assets for February. Shares of big U.S. banks, including JPMorgan Chase & Co (JPM.N), Citigroup (C.N), and Wells Fargo (WFC.N) all lost ground. The S&P 500 posted 1 new 52-week highs and 48 new lows; the Nasdaq Composite recorded 29 new highs and 526 new lows.

Washington-based Seagen is a pioneer of antibody-drug conjugates, which work like "guided missiles" designed for a targeted destructive effect and spare healthy cells. The Pfizer logo is pictured on their headquarters building in the Manhattan borough of New York City, New York, U.S., November 9, 2020. The drugmaker expects more than $10 billion in sales from Seagen products in 2030, and another $15 billion from its other recent acquisitions. Pfizer said antitrust regulators could closely review the deal due to its size but eventually approve it. Pfizer rival Merck & Co Inc (MRK.N) and Seagen were in advanced deal talks last year but those reportedly collapsed over antitrust concerns.

But your second thought is, how big was that crisis, how big were the risks that this step had to be taken?" Trading in shares of SVB's peer Signature Bank (SBNY.O), which was shut down by regulators on Sunday, was halted. Shares of big U.S. banks including JPMorgan Chase & Co (JPM.N), Morgan Stanley (MS.N) and Bank of America (BAC.N) fell between 2.8% and 6.3%. The KBW regional banking index fell 11.2%, while the S&P 500 banks index (.SPXBK) dropped 7.7%. The S&P index recorded no new 52-week highs and 44 new lows, while the Nasdaq recorded 19 new highs and 321 new lows.

Helping futures for the tech-heavy Nasdaq gain nearly 1%, U.S. two-year Treasury yields tumbled to more than a month low, while futures for the cyclicals-heavy Dow Jones edged lower. Big Tech and growth companies such as Meta Platforms (META.O), Amazon (AMZN.O) and Microsoft (MSFT.O) rose between 1% and 2% premarket. Traders' bets are currently equally split between a pause and a 25-basis-point rate hike at the Fed's next meeting in March. The projections of a terminal rate have also receded to just under 5% by June from around 5.5% in September earlier. ET, Dow e-minis were down 48 points, or 0.15%, S&P 500 e-minis were up 5.5 points, or 0.14%, and Nasdaq 100 e-minis were up 99.25 points, or 0.84%.

☆ Pfizer Agrees to Buy Seagen for $43 Billion
▼ + stars: | 2023-03-13 | by ( Jared S. Hopkins | Jonathan D. Rockoff | ) www.wsj.com time to read: 1 min

Pfizer has been looking for acquisitions to help it offset losses in sales. Pfizer Inc. has agreed to pay $43 billion for biotech Seagen Inc. and its pioneering class of targeted cancer drugs. Under the terms, Pfizer would pay $229 a share cash, the drugmaker said Monday. The companies expect the deal to close late this year or early next year.

☆ Pfizer signs $43 bln Seagen deal in cancer drug push
▼ + stars: | 2023-03-13 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

The deal, Pfizer's biggest in a string of acquisitions after a once-in-a-lifetime cash windfall from its COVID-19 vaccine and pill, will add four approved cancer therapies with combined sales of nearly $2 billion in 2022. Pfizer will pay $229 in cash per Seagen share, a 32.7% premium to Friday's closing price. The drugmaker expects more than $10 billion in "risk-adjusted" sales from Seagen in 2030. Pfizer's portfolio of oncology therapies includes 24 approved drugs, including breast cancer treatment Ibrance. Pfizer rival Merck & Co Inc (MRK.N) and Seagen were in advanced deal talks last year but that reportedly collapsed over fears of tough antitrust scrutiny.

☆ Big Companies Seeing Tax Benefits From Law Change Some of Them Fought
▼ + stars: | 2023-03-08 | by ( Richard Rubin | Jennifer Williams-Alvarez | ) www.wsj.com time to read: +6 min

Those companies now qualify for a bigger tax break for exports because of the way the research-deduction change alters their tax calculations. Photo: Dado Ruvic/REUTERSModerna saw that tax break jump to a 7.4 percentage-point benefit on its tax rate from 4.8 points in 2021, even as its cash tax payments rose. The change requiring companies to spread out research deductions was part of the 2017 tax law, and it was designed to partly offset the revenue loss from cutting corporate tax rates. PREVIEWAt the same time, the smaller research deduction means many companies can get a bigger advantage from the export tax break. The size of the FDII tax break is based in part on how much income a company has.

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