STAT

APRIL 5, 2024

When Francis Collins, then-director of the National Human Genome Research Institute, testified before Congress in 2003 about the significance of sequencing the human genome that year, he introduced personalized medicine as a new concept.

Diabetes 332

Diabetes 332

STAT

JANUARY 30, 2023

The human genome was sequenced in 2003. The act also created an industry that didn’t exist in the United States before its enactment, enabling the formation of companies to develop and commercialize therapies for rare diseases. That said, a lot has changed in science and drug development since 1983.

Drug Development 261

Drug Development 261

STAT

MARCH 6, 2023

That was the message Chinese scientists delivered Monday on the opening day of the Third International Summit on Human Genome Editing in London.

246

246

STAT

JUNE 1, 2023

billion in 2003 to $42.9 But that could end up hammering the NIH budget, which has steadily climbed over the years as Congress channeled billions of dollars to research on cancer, Alzheimer’s disease, and rare diseases. The NIH’s overall budget nearly doubled from $25.8 billion in 2022.

261

261

STAT

JANUARY 27, 2023

biomedical research powerhouse, a role he held from 2003 to 2021, when he was appointed to serve as the White House’s first Cabinet-level science adviser to the president. But the founding director will not be back at the helm of the Cambridge, Mass.,

254

254

STAT

NOVEMBER 1, 2022

The precedent established in 2003, when the court ruled that race, along with other factors, could be given limited consideration in higher education admissions when necessary to achieve student body diversity, is now in jeopardy.

Medical Schools 261

Medical Schools 261

STAT

NOVEMBER 8, 2022

In 2003, Pancho’s life changed forever. That’s when a car crash sent the 20-year-old farm worker into emergency surgery to repair damage to his stomach. The operation went well, but the next day, a blood clot caused by the procedure cut off oxygen to his brain stem, leaving him paralyzed and unable to speak.

246

246

STAT

APRIL 15, 2024

Advisors, a hedge-fund firm run by brothers Felix and Julian Baker, had in 2003 invested in Seagen, a developer of next-generation cancer treatments. Pfizer bought Baker Bros.  Pfizer bought the company for $43 billion last year.

291

291

STAT

SEPTEMBER 22, 2023

Yale and the VA agreed in 2003 to share royalties on patents with inventors from both institutions.  Yale and professor John Krystal agreed to pay $1.5 million to resolve claims that they failed to pay the VA its share of royalties for patents covering intranasal ketamine used to treat depression.

Department of Veterans Affairs 274

Department of Veterans Affairs Pharmacy Technician Compounding Pharmacies Compounding 274

Express Pharma

MARCH 16, 2025

The group now has 419 approvals and has so far filed 483* ANDAs since the commencement of the filing process in FY 2003-04. (*As Eluxadoline tablets had annual sales of USD 243.7 mn in the United States (IQVIA MAT January 2025). As of December 31, 2024.)

66

66

Express Pharma

MARCH 12, 2025

With this approval, Zydus Lifesciences now has 419 approvals and has filed a total of 483* Abbreviated New Drug Applications (ANDAs) since the filing process began in the financial year 2003-04. (*As As on 31 st December, 2024.)

66

66

Outsourcing Pharma

JUNE 7, 2021

The US Food and Drug Administration (FDA) has approved Biogenâs Aduhelm (aducanumab) for the treatment of Alzheimerâs: making it the first new treatment approved for the disease since 2003.

98

98

Pharma Mirror

OCTOBER 4, 2021

In 2003 the Human Genome Project provided the first atlas. Despite untold investment by numerous pharmaceutical companies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation.

Pharmaceutical Companies 119

Pharmaceutical Companies Pharmaceutical Companies 119

NY Times

JUNE 5, 2021

If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say there isn’t enough evidence it works.

81

81

Express Pharma

APRIL 22, 2024

The group now has 393 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04. Mirabegron Extended-Release Tablets USP 25mg and 50mg had annual sales of $2.42 billion in the US (IQVIA MAT February 2024). The post Zydus launches Mirabegron ER tablets in US appeared first on Express Pharma.

105

105

Express Pharma

APRIL 19, 2023

The group now has 363 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04. Roflumilast Tablets, 250 mcg had annual sales of $34 million in the United States (IQVIA MAT Feb. The post Zydus gets USFDA approval for Roflumilast Tablets, 250 mcg appeared first on Express Pharma.

105

105

Express Pharma

FEBRUARY 9, 2024

The group now has 387 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04. Dexamethasone Tablets USP, 1 mg had annual sales of $1.8 million in the United States (IQVIA Dec. The post Zydus gets tentative USFDA approval for Dexamethasone Tablets USP, 1 mg appeared first on Express Pharma.

Immunity 104

Immunity Immunization 104

ALiEM - Pharm Pearls

JUNE 15, 2023

Lancet 2003; 361 (9373): 1935-8. PMID 29855084 De Silva HA, Fonseka MM, Pathmeswaran A et al. Multiple dose activated charcoal for treatment of yellow oleander poisoning: A single-blind, randomized placebo controlled trial.

Hospitals 246

Hospitals 246

Express Pharma

OCTOBER 6, 2023

The group now has 381 approvals and has so far filed over 444* ANDAs since the commencement of the filing process in FY 2003-04. Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), SingleDose Vial had annual sales of $986 million in the United States (IQVIA MAT Aug 2023).

111

111

Express Pharma

MAY 13, 2024

The group now has 395 approvals and has so far filed over 460 (as of 31st December, 2023) ANDAs since the commencement of the filing process in FY 2003-04. Dexamethasone Tablets USP, 1 mg had annual sales of $ 1.8 million in the United States (IQVIA MAT March 24).

Immunity 90

Immunity Immunization 90

cureatr

AUGUST 10, 2023

Two decades after the Medicare Modernization Act of 2003 created Medicare Part D, nearly 50 million Americans are enrolled in a standalone prescription drug benefit program.

Medication Therapy Management (MTM) 78

Medication Therapy Management (MTM) 78

Orsini Pharmacy

FEBRUARY 27, 2023

In 2003, Tommy was diagnosed with Duchenne Muscular Dystrophy (DMD) , a genetic disorder where the body does not maintain muscle mass due to an inborn lack of the protein dystrophin. On Rare Disease Day, we are dedicating this blog to Tommy, a selfless and caring individual we had the opportunity to serve for several years.

85

85

The Guardian - Pharmaceutical Industry

SEPTEMBER 9, 2023

Now many believe the money might have been better spent on public health interventions After spending 13 years and $2.7bn, the Human Genome Project announced in 2003 that it had successfully mapped our DNA, paving the way for a new era of medicine that would deliver “the right treatment, for the right patient, at the right time”.

91

91

Express Pharma

FEBRUARY 8, 2024

The group now has 386 approvals and has so far filed over 448* ANDAs since the commencement of the filing process in FY 2003-04. Dexamethasone Tablets USP, 0.5 mg, 4 mg and 6 mg had annual sales of $22 million and Dexamethasone Tablets USP, 2 mg has annual sales of $6 million in the United States (IQVIA Dec.

105

105

Express Pharma

NOVEMBER 30, 2023

The group now has 382 approvals and has so far filed over 448* ANDAs since the commencement of the filing process in FY 2003-04. Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of $136.5 million in the United States (IQVIA MAT October,2023). The post Zydus gets US FDA final approval for Ivabradine Tablets, 5 mg and 7.5

105

105

Express Pharma

APRIL 5, 2023

The group now has 358 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04. Acetazolamide Tablets USP, 125 mg and 250 mg had annual sales of USD 16 mn in the United States (IQVIA MAT Dec.

98

98

Express Pharma

AUGUST 31, 2023

The group now has 378 approvals and has so far filed over 444 ANDAs since the commencement of the filing process in FY 2003-04. Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg had annual sales of $165 million in the United States (IQVIA MAT July 2023).

105

105

Express Pharma

APRIL 6, 2023

The group now has 359 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04. Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg had annual sales of $75 million in the United States (IQVIA MAT Dec.

96

96

Pharmacy Times

FEBRUARY 16, 2024

This marks omalizumab’s fourth FDA-approved indication for allergic and inflammatory conditions, such as severe persistent allergic asthma, with its initial approval being in 2003.

57

57

Eye on FDA

JANUARY 26, 2022

Eye on FDA maintains a database that contains the results of Warning and Untitled letters issued by OPDP going back through 2003. Warning Letters can be found performing a search here , while Untitled Letters are listed here. It includes 352 letters covering over 450 communications vehicles and over 1100 violations.

Communication 108

Communication Diabetes 108

FDA Law Blog: Biosimilars

MARCH 18, 2025

Merck applied for a patent term extension on the reissued patent, claiming the start of the regulatory review period as April 2004 and termination at the approval of the BRIDION NDA in December 2015.

Drug Pricing 59

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 59

Express Pharma

JUNE 27, 2023

Announcing Gagandeep’s appointment, Mohammed Tawil, Regional Managing Director and Head of Human Pharma for India, Middle East, Turkey, and Africa at Boehringer Ingelheim said, “Since inception in 2003, our focus on improving patient outcomes in India remains steadfast.

Communication 98

Communication Pharmaceutical Companies Pharmaceutical Companies 98

Big Molecule Watch

SEPTEMBER 6, 2024

The PTAB now has granted institution of Sarepta’s IPR, which challenges claims 1, 3-6, and 8 of the ’274 patent as obvious over four prior art references: US 2003/0138772 A1 (“’772 Publication”), Qing Xie et al., 10405–10410 (2002) (“Xie”), Stephen Snowdy, Nuclear targeting by adeno-associated virus capsid proteins and virions (2003) (Ph.D.

49

49

European Pharmaceutical Review

JULY 11, 2024

Dr Thakkar joined Abbott/AbbVie in 2003 and has progressed through several positions in clinical development, including group project director, immunology, as well as vice president and global regulatory affairs. In 2019, Dr Thakkar took on the role of vice president, global regulatory affairs and R&D quality assurance.

105

105

pharmaphorum

NOVEMBER 13, 2020

Palantir was founded in 2003 by a team including paypal co-founder Peter Thiel and the company’s billionaire CEO Alex Karp. Palantir has been linked with the project for several weeks and the Financial Times is the latest to suggest that the company could get involved with the troubled project.

Documentation 112

Documentation 112

Express Pharma

FEBRUARY 21, 2024

10 crore, as they are not based in states which enjoyed tax holidays from 2003 to 2017. The remaining 20 per cent would be unable to produce medicines for PMJK or most of the NLEM medicines because the production cost post implementation of the Revised Schedule M would be higher than the permitted MRPs.

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing 105

pharmaphorum

DECEMBER 8, 2022

The advent of biologic therapies in the 1970s along with the decoding of the human genome in 2003 heralded an explosion in pharmaceutical innovation.

Drug Development 96

Drug Development 96