Patient Safety Capsules
Revising DT limit for Soft Gelatin Capsules: Pharma Industry seek solutions
May 17, 2023, The IPC has proposed a reduction of the DT from 60 minutes to 30 minutes for all product categories.However, the industry highlights an important distinction between Indian regulations and the United State Pharmacopoeia (USP).
Des Moines Walgreens store faces new charges of prescription-filling errors
MAY 9, 2023: A Des Moines pharmacy already on probation has been fined $5,000 for incorrectly filling customers’ prescriptions.
Drug Laws & Policy Injections
House Co-Chair and State Prosecutor Clash Over US$100M Drug Ruling in Landmark Cocaine Trial Acquittal
May 25, 2023: MONROVIA – A clash has ensued between the Co-Chairman of the House of Representatives Committee on National Defense and Security Representative Samuel Kogar, and the former Special Assistant to the Solicitor General Counselor Lafayette Gould, over a non-guilty verdict rendered by the court in the historic US$100M drug case in the country.
Drugs seized in Indian waters worth Rs 25,000 cr, confirms NCB
middle May 15, 2023: The value of drugs seized in a special operation by the Narcotics Control Bureau (NCB) and Indian Navy in Indian waters on Saturday was priced at Rs 25,000 crores after enumeration, informed NCB on Monday.
Governor DeWine Announces $3 Million to Help Law Enforcement Combat Illegal Drug Activity
May 26, 2023: Grants from the 2023 Ohio Drug Law Enforcement Fund will support drug task forces that impact 42 counties on issues of drug trafficking, pharmaceutical diversion, and other organized criminal activity associated with the drug trade. The program, which is administered through the Office of Criminal Justice Services, is also intended to help local agencies enhance the safety of Ohioans through multi-jurisdictional task forces.
U.S. Supreme Court rules against Amgen bid to revive cholesterol drug patents
May 19, 2023: The 9-0 ruling upheld a lower court's decision that had invalidated Amgen's patents on the grounds that the Thousand Oaks, California-based drugmaker had failed to provide a roadmap for recreating, or "enabling," the full scope of its claimed innovation.
Singapore’s death row ‘main element of its drug policy’ 16 May, 2023: Singapore’s use of the death penalty was once again thrust into the global spotlight last month when Tangaraju Suppiah became the first person to be executed in the city-state this year.
Pharma Injections
Pharma major Pfizer asks doctors to stop using these life-saving antibiotics; Here’s why
May 18, 2023: Pfizer, an American pharmaceutical company, has warned doctors in India to stop using some of its life-saving antibiotics, especially for patients in intensive care units (ICUs).
Y-mAbs’ Danyelza injection receives marketing approval in Brazil
May 24, 2023: Danyelza will be given three times in a week to patients and the dosage will be repeated every four weeks.Y-mAbs Therapeutics has received marketing authorisation for Danyelza (naxitamab-gqgk) 40mg/10mL injection from the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária, to treat high-risk neuroblastoma.
Aurobindo Pharma arm copy of Pfizer’s drug gets U.S. FDA nod
May 26, 2023: Aurobindo Pharma subsidiary Eugia Pharma Specialties has received the final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Carboprost Tromethamine Injection USP 250 mcg/mL, single-dose vials.
Shilpa Medicare gets USFDA approval for lung cancer injection Pemetrexed
May 23, 2023: Karnataka: Shilpa Medicare has announced that the company ’s New Drug Application for Pemetrexed Injection 1000 mg/100 ml, 500 mg/50 ml & 100 mg/10 ml, Ready to Use formulation is approved by US Food and Drug Administration (US FDA).
Endo enters agreement with MAIA Pharma to distribute bivalirudin injection in ready-to-use vials in US markets May 25, 2023: Endo International plc, a specialty pharmaceutical company, announced that its subsidiary Endo Ventures Limited has executed an agreement with MAIA Pharmaceuticals, Inc. to distribute bivalirudin injection in a ready-to-use 250 mg/50 mL single-use vial in the US. Endo will commercialize the FDA-approved product through its Par Sterile Products business and expects to begin shipping in summer 2023.
Pfizer recalls three anti-bacterial injections in India manufactured by Astral SteriTech May 18, 2023: Drug firm Pfizer on Thursday said it is recalling in India all batches of three anti-bacterial injections manufactured for it by Astral SteriTech Pvt Ltd. In a regulatory filing, the company said it has decided to initiate a voluntary recall of Magnex (1gm, 2gm), Magnex Forte (1.5gm, 3gm), Zosyn (4.5gm) and Magnamycin (250mg, 1gm, 2gm) after observing 'out-of-specification' deviation during a routine environmental monitoring at Astral SteriTech's manufacturing block.
Drug Dopes
Death of a 43-year-old male marks the entry of 'zombie' drug into the UK May 26, 2023: The death of a 43-year-old male is the first in the UK to be associated with Xylazine and marks the entry of the drug into the UK drug supply.
to experts. 
Worrying veterinary drug dangerous to humans May 27, 2023: Xylazine is a veterinary tranquilizer that is not approved for human use. It also goes by the names “tranq,” “tranq dope,” and “zombie drug.” Xylazine is becoming an issue because it is being “cut” or diluted with other chemicals in street drugs to increase profit.
90-day drug dealing crackdown in S.F.? Why dealers and users say it
May 26, 2023: Word that city honchos are talking about erasing out-in-the-open clusters of drug dealing in San Francisco in just 90 days drew a mixture of chuckles, shrugs and a few hopeful sighs from people pushing and using drugs and the fed-up businesses around them.
Maintain a degree of competitiveness to consolidate our presence in the world, says Dr Mansukh Mandaviya May 27, 2023: Union minister of chemicals and fertilizers, and health and family welfare Dr Mansukh Mandaviya said that the industry is progressing at a rapid rate, and to maintain India's stature as the ‘Pharmacy of the World’, we need to focus on quality and affordable manufacturing with an increased focus on research and innovation.
Kristin Judge joins Emmes as chief growth officer
May 27, 2023: Emmes, a global, full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation has announced that Kristin Judge has joined as its chief growth officer, a newly created executive leadership position.
National Injections
Pfizer oral weight loss drug may be as effective as Ozempic injection by Novo Nordisk, study says
May 27, 2023: An oral drug from Pfizer causes a similar amount of weight loss as the blockbuster Ozempic injection, made by rival Novo Nordisk, according to results from a phase two clinical trial. The results were presented at a medical conference late last year but JAMA Network now has released the full peer-reviewed study.
Tampered eye drugs were distributed in Newfoundland and Labrador, documents show
May 18, 2023: Thousands of patients in Newfoundland and Labrador could have received tampered eye medications without their knowledge for several years, documents obtained by CBC News reveal. The drugs in question are injectable doses of Eylea and Lucentis, used to treat age-related macular degeneration. More than two million Canadians suffer from the condition, the leading cause of irreversible vision loss.
A quarter of people now back lethal injections for the POOR and homeless
25 May 2023: Canada is under fire once again as host of the world's most permissive assisted suicide program, where millions of people now say the homeless and poor should be eligible for state-sanctioned deaths. A survey released this month found that more than a quarter of Canadians say being impoverished or unhoused is a good enough reason for a doctor to inject somebody with a deadly cocktail of drugs.
Safe Injection Sites Study Aims to Rise Above the Politic
May 18, 2023: The launch of a federally funded study to examine the efficacy of drug overdose prevention centers in the U.S. could have broad policy implications as jurisdictions across the country consider opening such sites to combat the human toll of the opioid crisis.
Editorial: Injection of evidence: Research can help solidify overdose prevention effectiveness
May 15, 2023: The National Institutes of Health is launching a four-year study of users of the two overdose prevention centers in New York and an upcoming one in Rhode Island. The evidence for these centers’ benefits is already strong, but this study can make it bulletproof
Global Injections
Venus Remedies secures Kenyan GMP certification for all its manufacturing facilities in Baddi
May 23, 2023: Venus Remedies Limited, a leading research-based pharmaceutical company, has achieved another significant milestone by securing a Good Manufacturing Practices (GMP) certification from Kenya for all its production facilities in Baddi.
Landmark $70m Series D funding injection boosts Nymbus
May 26, 2023: Nymbus, a leading provider of financial technology solutions, has announced the culmination of its Series D funding round, amounting to $70m. The substantial funding round was facilitated by the involvement of both new and repeat investors.
UK Government Boosts AMR Research with Cash Injection
May 24, 2023: The United Kingdom’s government has announced a significant cash injection, worth £39 million (US$48 million), will be made to support antimicrobial resistance (AMR) research through the Global AMR Innovation Fund (GAMRIF).
Oxytocin Injection Market Size, Industry Report Analysis, Growth, Future Trends, Top Manufacturers And Forecast to 2030
May 26, 2023: A Latest intelligence report published by Data Bridge Market Research with title "Oxytocin Injection Market Outlook, Companies, Regions, Type And Application and Forecast. A detailed study accumulated offers a complete overview of various key elements impacting positively or negatively on the overall growth features of the Oxytocin Injection market.
Injection Pen Market Size is Projected To Reach USD 80,511.51 Million By 2031, Growing at a CAGR of 7.8% | Valuates Reports
PSAIIF PILL
BOE Chief Economist says higher migration will boost UK economy
May 23, 2023: Bank of England Chief Economist Huw Pill said higher-than-expected migration had added 20 basis points to the Bank’s economic growth forecasts, underscoring the UK’s need for workers to fill jobs.
US FDA approves Pfizer’s Paxlovid to treat adult patients at high risk of progression to severe Covid-19
May 27, 2023: Pfizer Inc. announced that the US Food and Drug Administration (FDA) approved Paxlovid (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate Covid-19 in adults who are at high risk for progression to severe Covid-19, including hospitalization or death. Paxlovid has been available in the US since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain consistent with the EUA. More than 11.6 million treatment courses of Paxlovid have been prescribed in the US to date.
Frequently Asked Questions
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Vaccination is one of the best ways parents can protect infants, children, and teens from 16 potentially harmful diseases that can be very serious, may require hospitalization, or even be deadly.
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SUBSCRIBER'S SYMPTOM
Threat Of Pathogen Emerging With 'Even Deadlier Potential' Remains: WHO Chief
May 24, 2023: The World Health Organisation's head Tedros Adhanom Ghebreyesus has cautioned about the possibility of a more deadly pandemic in the future, even as COVID-19 cases appear to be stabilising around the globe.
Sought Out by Science, and Then Forgotten
May 23, 2023: José Echeverría spends restless days in a metal chair reinforced with boards and padded with a piece of foam that his mother, Nohora Vásquez, adjusts constantly for his comfort. The chair is coming loose and will soon fall apart. Huntington’s disease, which causes José to move his head and limbs uncontrollably, has already left one bed frame destroyed. At 42, he is still strong.
Blog Addicts
Dr. Ranjit Shahani Excellent articles
being published every edition. Very enjoyable. S. S. AgarwalIndeed a pleasure to
receive the newsletter and read it. Well done.
Dr. Yusuf Hamied, MBBSPresented very
beautifully and aptly captures important developments in the Pharma space
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