STAT

MAY 10, 2023

Reviewers at the Food and Drug Administration concluded that Sarepta Therapeutics did not show that its gene therapy for Duchenne muscular dystrophy will likely benefit patients and left key safety concerns, according to briefing documents released Wednesday.

Documentation 246

Documentation 246

STAT

NOVEMBER 15, 2022

However, a STAT   review of documents detailing   the steps taken toward government approval found that regulators endorsed the vaccine, called Covaxin, despite discrepancies in the number of clinical trial participants.

Documentation 364

Documentation Vaccines 364

Pharmacy Joe

MARCH 27, 2024

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document. appeared first on Pharmacy Joe.

Documentation 98

Documentation Inpatient 98

STAT

APRIL 12, 2023

The settlement, which includes California and New York, is the largest to date between Juul and state attorneys general, and will also require Juul to disclose a number of previously secret documents, which will be housed in an academic archive. Read the rest…

Documentation 227

Documentation 227

STAT

OCTOBER 6, 2022

In the run-up to an extremely unusual hearing later this month, newly released documents underscore highly contrasting views taken by the U.S. Food and Drug Administration and a manufacturer toward a controversial drug for reducing premature births, which the agency wants withdrawn from the market.

Documentation 240

Documentation 240

STAT

JANUARY 29, 2024

LONDON — There was something odd about these Alzheimer’s cases. Part of it was the patients’ presentations: Some didn’t have the classic symptoms of the condition. But it was also that the patients were in their 40s and 50s, even their 30s, far younger than people who normally develop the disease.

Documentation 364

Documentation 364

RX Note

OCTOBER 9, 2023

Since we don't even remember what we eat this morning, it is vital to make proper medical documentation. The amendments should be documented on the prescription and endorsed with “prescriber contacted” (PC), dated and initialled by the pharmacist/person dispensing.

Documentation 52

Documentation Medical Records 52

STAT

OCTOBER 27, 2023

The Food and Drug Administration said on Friday that it has some safety concerns about an experimental CRISPR-based treatment for sickle cell disease, citing the methods used by its makers to evaluate the risk of inadvertently making unwanted changes to patients’ DNA.

Documentation 350

Documentation 350

STAT

MARCH 20, 2024

Johnson & Johnson has accused a long-standing employee of taking thousands of confidential files about commercial strategies as he left for a similar job at Pfizer, according to lawsuit filed in a federal court in New Jersey.

Documentation 313

Documentation 313

BioPharma Dive

MAY 10, 2023

Sarepta has not provided “unambiguous evidence” its treatment can help patients, agency scientists wrote in documents released ahead of a crucial Friday advisory committee meeting.

Documentation 114

Documentation 114

Pharmacy Joe

MARCH 27, 2024

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document. appeared first on Pharmacy Joe.

Documentation 52

Documentation Inpatient 52

STAT

MAY 16, 2023

An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the Food and Drug Administration said Tuesday in an analysis of the data generated to support licensure of the vaccine.

Vaccines 241

Vaccines Documentation 241

PioneerRx

MARCH 8, 2023

Save valuable time in your workflow with the Incoming Documents and Faxes tool, available in PioneerRx’s pharmacy software.…

Documentation 52

Documentation 52

GMPSOP

APRIL 3, 2023

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

STAT

APRIL 11, 2024

Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer have projected — according to a document obtained by STAT.

Documentation 363

Documentation 363

STAT

OCTOBER 14, 2022

In 2011, Walgreens executives were under pressure. Amid a growing addiction crisis, and with the country already awash in prescription painkillers, the federal government was demanding accountability from the pharmacy giant for filling thousands of opioid prescriptions written by doctors in suspiciously large quantities.  

Documentation 304

Documentation 304

STAT

DECEMBER 16, 2022

My grandmother died in the hospital, alone, the day after she was “found down” at home by emergency medical services. I lived near my Nani, as I called her but, even though I am a physician, was not allowed to see her after she had been admitted to her local hospital because of the strict, Covid-related no-visitor policy.

Documentation 266

Documentation Hospitals 266

pharmaphorum

NOVEMBER 13, 2020

Join us at our 2nd Clinical Document World Virtual event on January 19-21, 2021, alongside your TMF, clinical quality, document management, and clinical professionals to explore a strategic clinical process and ensure a complete Document Management Process. Focus on ensuring high quality documentation.

Documentation 52

Documentation 52

Pharma Pathway

JANUARY 6, 2023

Walk-Ins for Quality Control/ Production/ Production Documentation/ EHS On 7th Jan’ 2023. Walk-Ins for Quality Control/ Production/ Production Documentation/ EHS On 7th Jan’ 2023. Department: Quality Control/ Production/ Production Documentation/ EHS. Dasami Lab Pvt. Job Description. Dasami Lab Pvt. Dasami Lab Pvt.

Documentation 83

Documentation 83

Pharmafile

APRIL 25, 2023

The National Institute for Health and Care Excellence (NICE) has submitted a Final Appraisal Document (FAD) for the use of Darzalex (daratumumab) with bortezomib and dexamethasone (DVd) for adults with previously treated multiple myeloma. read more

Documentation 59

Documentation Communication 59

BioPharma Dive

SEPTEMBER 1, 2023

The newly posted documents show the agency had concerns about the side effects experienced by people with clinical depression who took Sage’s drug, Zurzuvae.

Documentation 58

Documentation 58

STAT

FEBRUARY 15, 2024

WASHINGTON — A new trove of internal emails and other documents from the e-cigarette maker Juul reveals the company’s extensive behind-the-scenes efforts to promote its interests in Washington — a rare insight into the otherwise opaque methods corporations use to influence the government.

Documentation 357

Documentation 357

Pharma Pathway

SEPTEMBER 17, 2022

Dasami Labs-Walk-In Drive for Quality Control/ Production/ AQA / Production Documentation/ Engineering On 18th Sept’ 2022. Walk-In Drive for Quality Control/ Production/ AQA / Production Documentation/ Engineering On 18th Sept’ 2022 On 18th Sept’ 2022 @ Dasami Labs. Job Description. Greetings from Dasami Labs !!! Contact: 9100037271.

Documentation 89

Documentation 89

STAT

APRIL 26, 2024

New federal rules aimed at limiting the spread of the H5N1 bird flu virus among dairy cattle go into effect Monday, but detailed guidance documents released Friday by the U.S. Department of Agriculture reveal its mandatory testing order is less stringent than initially described.

Documentation 362

Documentation 362

Putting Patients First Blog

APRIL 29, 2024

Recognizing both the potential benefits and challenges of the MPPP rollout, the NHC views the introduction of these documents as crucial for educating beneficiaries on their options, easing transitions, and possibly lessening the financial impact of prescription costs.

Documentation 40

Documentation Insurance Coverage and Processing Communication Pharmacy Technician 40

Big Molecule Watch

MAY 25, 2023

On May 23, 2023, Amgen filed a motion to intervene in the case “for the limited purpose of invoking the First Amendment and common law rights of public access to judicial records in order to unseal documents that were previously sealed.” common law. The post Amgen Intervenes in Regeneron v.

Documentation 62

Documentation Biosimilars 62

STAT

DECEMBER 28, 2023

Health insurance giant UnitedHealth Group used secret rules to restrict access to rehabilitation care requested by specific groups of seriously ill patients, including those who lived in nursing homes or suffered from cognitive impairment, according to internal documents obtained by STAT.

Nursing Homes 364

Nursing Homes Documentation 364

Pharma Pathway

JANUARY 5, 2023

SMS Lifesciences India Limited- Walk-In Interviews for Production/ Production Documentation/ Maintenance On 7th Jan’ 2023. Walk-In Interviews for Freshers & Experienced in Production/ Production Documentation/ Maintenance @ SMS Lifesciences India Limited. Departments: Production/ Production Documentation/ Maintenance.

Documentation 73

Documentation 73

PharmaTech

MARCH 23, 2023

The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

Documentation 52

Documentation 52

Express Pharma

MAY 19, 2023

“Tweak in policy is mooted,” the document from the prime minister’s office said, adding that “important things” had been “overlooked” It did not elaborate. .” The post India considers policy change after cough syrup deaths, a document from PM’s office appeared first on Express Pharma.

Documentation 75

Documentation Generic Medicine 75

Pharmacy Times

MARCH 18, 2024

Michael Singel, PharmD, discusses the logistics of complying with the Risk Evaluation and Mitigation Strategy program for bispecific antibodies at his institution and addresses training and documentation requirements.

Documentation 26

Documentation 26

Syner-G

SEPTEMBER 20, 2023

Challenge Syner-G was contracted by a US Pharmaceutical Company to help improve the quality of submission documentation generated during the manufacture of a Drug Substance intended for Phase II trials. Results Syner-G reviewed each documentation and provided suggestions/comments/guidance to the CDMO to bridge the gaps observed.

Documentation 40

Documentation Pharmaceutical Companies Pharmaceutical Companies Communication 40

Outsourcing Pharma

JANUARY 28, 2022

A representative from IQVIA discusses the particulars of the US agencyâs new draft document and shares what it might mean for clinical trial data evaluation.

Documentation 69

Documentation 69

Pharma in Brief

SEPTEMBER 5, 2023

The Court found that Health Canada had breached the duty of procedural fairness by relying on a product classification factor in an internal guidance document that Health Canada only published after rendering its decision. Background Organigram Inc. manufactures Edison Jolts ( Jolts ), which are cannabis products in lozenge form.

Documentation 52

Documentation 52

STAT

APRIL 30, 2024

The H5N1 bird flu virus has been around for decades, and the damage it wreaks on chickens and other poultry is well documented. But the recent discovery that the virus has jumped into dairy cattle — whose udders seem to be where the virus either infects or migrates to — has dumbfounded scientists and agricultural authorities.

Documentation 363

Documentation 363

STAT

OCTOBER 25, 2023

Novartis has gone to court to gain access to Takeda Pharmaceutical documents over concerns that a former employee took trade secrets with him to his new job at the rival drugmaker. Continue to STAT+ to read the full story…

Documentation 271

Documentation 271

STAT

NOVEMBER 20, 2023

Financial documents at a prominent hospital system in Los Angeles show just how large those discounts are — and how raw of a deal uninsured patients could be getting. 30, according to new financial documents. Hospitals’ list prices for surgeries, therapies, and other procedures always come with massive discounts.

Hospitals 333

Hospitals Documentation 333