The Market Return To Pharmaceutical Product Approval PDF

Please forward this error screen to cloud05. Glivec, a drug used in the treatment of several cancers, is marketed by Novartis, one of the world’s major the Market Return To Pharmaceutical Product Approval PDF companies. The modern pharmaceutical industry traces its roots to two sources.


Författare: Imtiaz Ahmed.
The stock and securities market should, ideally,
react quickly (efficiently) in response to the
public announcement of approval of new drug by the
Food and Drug Administration (FDA) and the positive
abnormal return may be expected for the sponsoring
pharmaceutical company on and around the event date
i.e. the day of the public announcement of the new
drug approval for marketing. This study has found
the mixed outcomes. Briefly, the findings are: (a)
Existence of statistically significant positive
abnormal returns (AR) for the day following the
events. (b) The cumulative abnormal return (CAR) is
statistically insignificant for the estimates of the
pooled regressions and for some of the individual
pharmaceutical companies. (c) No sign of information
leakage ahead of the events. (d) Some individual
pharmaceutical companies show the existence of
statistically significant positive abnormal returns
(AR) and the cumulative abnormal return (CAR) for
event day and the day after (e.g. Novartis, Abbott,
Schering Plough). These findings may play a
significant role in the decision making process of
mutually exclusive investments in the pharmaceutical
products.

The first of these were local apothecaries that expanded from their traditional role distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid 1800s. By the 1890s, the profound effect of adrenal extracts on many different tissue types had been discovered, setting off a search both for the mechanism of chemical signalling and efforts to exploit these observations for the development of new drugs. While highly effective, the requirement for injection limited the use of epinephrine and orally active derivatives were sought. Diethylbarbituric acid was the first marketed barbiturate.

In 1903, Hermann Emil Fischer and Joseph von Mering disclosed their discovery that diethylbarbituric acid, formed from the reaction of diethylmalonic acid, phosphorus oxychloride and urea, induces sleep in dogs. A series of experiments performed from the late 1800s to the early 1900s revealed that diabetes is caused by the absence of a substance normally produced by the pancreas. In 1869, Oskar Minkowski and Joseph von Mering found that diabetes could be induced in dogs by surgical removal of the pancreas. In 1911 arsphenamine, the first synthetic anti-infective drug, was developed by Paul Ehrlich and chemist Alfred Bertheim of the Institute of Experimental Therapy in Berlin. The drug was given the commercial name Salvarsan. Ehrlich’s approach of systematically varying the chemical structure of synthetic compounds and measuring the effects of these changes on biological activity was pursued broadly by industrial scientists, including Bayer scientists Josef Klarer, Fritz Mietzsch, and Gerhard Domagk.

In 1928, Alexander Fleming discovered the antibacterial effects of penicillin, but its exploitation for the treatment of human disease awaited the development of methods for its large scale production and purification. These were developed by a U. British government-led consortium of pharmaceutical companies during the Second World War. Early progress toward the development of vaccines occurred throughout this period, primarily in the form of academic and government-funded basic research directed toward the identification of the pathogens responsible for common communicable diseases. Prior to the 20th century drugs were generally produced by small scale manufacturers with little regulatory control over manufacturing or claims of safety and efficacy.

To the extent that such laws did exist, enforcement was lax. In the United States, increased regulation of vaccines and other biological drugs was spurred by tetanus outbreaks and deaths caused by the distribution of contaminated smallpox vaccine and diphtheria antitoxin. In 1937 over 100 people died after ingesting „Elixir Sulfanilamide“ manufactured by S. The product was formulated in diethylene glycol, a highly toxic solvent that is now widely used as antifreeze. A Federal Trade Commission report issued in 1958 attempted to quantify the effect of antibiotic development on American public health. Measles cases 1944-1964 follow a highly variable epidemic pattern, with 150,000-850,000 cases per year. A sharp decline followed introduction of the vaccine in 1963, with fewer than 25,000 cases reported in 1968.