TENTATIVE APPROVAL
Alembic Pharma gets tentative nod from USFDA for Ivosidenib tablets
The company said Ivosidenib tablets are indicated for patients with newly diagnosed Acute Myeloid Leukemia (AML) as monotherapy in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
Zydus Lifesciences gets tentative approval from USFDA for BP lowering drug
Zydus Lifesciences announced on Thursday that it has received tentative approval from the US Food and Drug Administration (USFDA) to market its generic Azilsartan Medoxomil tablets, which are used to treat high blood pressure. The USFDA's tentative approval covers Azilsartan Medoxomil tablets in strengths of 40 mg and 80 mg.
Indoco Remedies gets USFDA nod to market generic diabetes drug
Indoco Remedies on Thursday said it has received approval from the US health regulator to market a generic diabetes medication. The company has received tentative approval from the US Food and Drug Administration (USFDA) for abbreviated new drug application (ANDA) for Canagliflozin and Metformin Hydrochloride tablets in various strengths, Indoco Remedies said in a regulatory filing.
RAW official linked to assassination plot of Khalistan separatist leader Gurpatwant Singh Pannun in US, approved by ex-chief: Report
An investigative report reveals that a RAW official, Vikram Yadav, was involved in an assassination plot against Khalistan separatist leader Gurpatwant Singh Pannun in the US, approved by ex-chief Samant Goel. Pannun is a key figure in the Khalistan movement. The report, published by The Washington Post, indicates broader involvement of RAW officials. The Biden administration has refrained from making charges against Yadav, with Nikhil Gupta, an alleged middleman, facing charges of hiring a contract killer.
Tesla soars 12% on tentative approval for driving system in China
The developments came after Tesla Chief Executive Officer Elon Musk made an unannounced trip to China on Sunday, seeking approval for driver-assistance software that could help arrest the carmaker’s revenue decline. While the company’s suite of features require constant supervision and don’t make Teslas autonomous, the company charges $8,000 for them in the US, or $99 a month for a subscription.
Alembic Pharma gets tentative USFDA nod for breast cancer drug
The medicine is indicated for the treatment of adult patients with a certain type of advanced or metastatic breast cancer in a combination of drug therapy.
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IMF board approves $700 million disbursement for Pakistan
The IMF's executive board approved an immediate disbursement of around $700 million for Pakistan Thursday. The funds were unlocked after the International Monetary Fund board approved the first review of a nine-month, $3 billion loan agreement reached in July 2023. The IMF said that macroeconomic conditions in Pakistan had "generally improved" since the program was implemented.
Actors vote to approve deal that ended strike, bringing relief to union leaders and Hollywood
Hollywood actors voted to ratify a three-year contract with studios, ending their nearly four-month strike, with 78% approval from members of the Screen Actors Guild-American Federation of Television and Radio Artists. The outcome, though not as unanimous as the writers' guild deal in September, is a major relief for the industry. The agreement addresses the use of artificial intelligence, a contentious issue in negotiations.
Hollywood actors reach tentative deal with studios to end strike
Hollywood actors reached a tentative agreement with major studios on Wednesday to resolve the second of two strikes that rocked the entertainment industry as writers and performers demanded higher pay in the streaming TV era. The 118-day work stoppage will end officially just after midnight, the SAG-AFTRA union said in a statement after its negotiating committee unanimously backed the deal with Walt Disney, Netflix and other companies.
118-day strike to end soon? Hollywood actors reach tentative deal with studios
Hollywood actors have reached a tentative deal with studios to end their months-long strike, the Screen Actors Guild (SAG-AFTRA) said Wednesday.
Hollywood actors, studios reach tentative deal to end strike: Union
"In a unanimous vote this afternoon, the SAG-AFTRA TV/Theatrical Committee approved a tentative agreement... bringing an end to the 118 day strike," a spokeswoman said in a statement.
General Motors reaches tentative agreement with UAW, potentially ending 6-week strike
General Motors (GM) and the United Auto Workers (UAW) union have reportedly reached a tentative contract agreement, offering hope for a resolution to the six-week-long strike affecting Detroit automakers. This development comes from a source with knowledge of the deal, who disclosed the information on Monday.
Chicago: Mayor Johnson, police union reach agreement to increase salary for officers
The city of Chicago and the union representing its police officers have reached a tentative agreement on a four-year contract. The contract includes a 20% raise for officers and aims to increase accountability within the department. The agreement extends the current contract by two years and includes annual pay increases of 2.5% to 5%. A $2,000 retention bonus will be replaced by a one-time bonus for all officers. The deal still needs approval from the City Council's Committee on Workforce Development and the full City Council.
Hollywood writers vote to approve contract deal that ended strike as actors negotiate
Hollywood writers have voted overwhelmingly to approve the contract agreement that ended their strike after nearly five months. The Writers Guild of America announced that 99% of their members voted to ratify the deal, which includes major gains in payment, show staff size, and control of artificial intelligence in scripts.
Hollywood writers' strike may come to an end as studios conclude a tentative truce with agitators
The agreement comes just five days before the strike would've become the longest in the guild's history, and the longest Hollywood strike in decades.
Striking Hollywood writers reach tentative deal with studios
In a brief statement, the Writers Guild of America said the agreement was "made possible by the enduring solidarity of WGA members and extraordinary support of our union siblings who joined us on the picket lines for over 146 days."
Smallcap pharma stock jumps over 11% as arm receives tentative USFDA approval for HIV drug Dolutegravir
The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with the USFDA, of which 230+ ANDAs have been approved. The company is eyeing around 60 new product launches over the next three years in the US.
Strides Pharma arm gets USFDA tentative nod for generic HIV treatment drug
Strides Pharma Global, a subsidiary of Strides Pharma Science, has received tentative approval from the US FDA for its generic Dolutegravir tablets used in HIV treatment. The approval allows the company to participate in global donor-funded programs that procure the medicine.
Google reaches tentative settlement with 36 states and DC over alleged app store monopoly
The agreement, cited in a court filing late Tuesday by both sides, is subject to approval by the state attorneys general and the board of directors of Google's parent company, the execution of an agreement and court approval.
Google reaches tentative settlement in US Play Store lawsuit
Consumers claimed they might have spent less on apps and had more options if it weren't for the alleged monopoly. Google had denied wrongdoing and declined to comment on the proposed settlement.
Zydus Lifesciences gets tentative nod from USFDA for generic breast cancer drug
The drug is used to treat a certain type of breast cancer. It works by slowing or stopping the growth of cancer cells. The product will be manufactured at the group's formulation manufacturing facility in SEZ, Ahmedabad.
Midcap stock zooms 9% on receiving USFDA approval for glaucoma drug
Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Granules India receives USFDA approval for generic gabapentin tablets
These tablets are bioequivalent to the reference listed drug product, Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty LLC.
Lupin gets tentative USFDA approval to market generic valbenazine capsules
These are the generic equivalent of Ingrezza capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc, it added. Valbenazine capsules had estimated annual sales of USD 1,235 million in the US, the company said, citing IQVIA MAT December 2022 data.
Lupin gets tentative USFDA nod for Dolutegravir, Emtricitabine and Tenofovir Alafenamide tablets
The tentative approval by the United States Food and Drug Administration (USFDA) has been granted under the President's emergency plan for AIDS relief (PEPFAR), Lupin said in a regulatory filing.
EU tentatively backs $60-per-barrel price cap on Russian oil
The European Union tentatively agreed to a USD 60-per-barrel price cap on Russian oil, a key step as Western sanctions aim to reorder the global oil market to prevent price spikes and starve President Vladimir Putin of funding for his war in Ukraine.
EU tentatively agrees $60 price cap on Russian seaborne oil
The agreement still needs approval from all EU governments in a written procedure by Friday. Poland, which had pushed for the cap to be as low as possible, had as of Thursday evening not confirmed if it would support the deal, an EU diplomat said.
Alembic Pharma gets tentative USFDA approval for depressive disorder drug
Citing IQVIA data, the company said these Vortioxetine tablets have an estimated market size of USD 1,249 million for twelve months ending September 2021. Alembic, however, said it is currently in litigation with H Lundbeck in the Court of appeals for the Federal Circuit and the launch of the product will depend on litigation outcome.
Shilpa Medicare gets tentative American health regulator nod for Apremilast tablets
The company has received tentative approval from US Food and Drug Administration for its abbreviated new drug application (ANDA) Apremilast tablets in the strengths of 10 mg, 20 mg, and 30 mg, Shilpa Medicare said in a regulatory filing.
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